Implant specific drill bit in surgical kit for cartilage repair

ABSTRACT

A drill tool for implant surgery including a first drill part having a first, smaller diameter for drilling a recess for an implant post and a second drill part having a second, larger diameter for drilling a recess for an implant hat is disclosed. The second drill part has one or more shape cutting edges and one or more sharp pre-cutting edges extending beyond said one or more shape cutting edges.

CROSS-REFERENCE TO PRIOR APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 14/342,302, now U.S. Pat. No. 9,254,196, issued Feb. 9, 2016,which is a § 371 National Stage Application of PCT InternationalApplication No. PCT/EP2012/067024 filed Aug. 31, 2012, which claimspriority to European Patent Application No. 11179923.5 filed Sep. 2,2011 and U.S. Provisional No. 61/530,497 filed Sep. 2, 2011, each ofwhich is herein incorporated by reference in its entirety.

FIELD OF THE DISCLOSURE

This disclosure relates in general to the field of orthopedic surgeryand to surgery kits, kits of tools and medical implants. Moreparticularly the present disclosure relates to a modular surgical kitcomprising a guide base and a guide body for use with a set of surgicaltools. The surgical kit is to be used for replacement or repair ofdamaged cartilage at an articular surface in a joint such as a knee,hip, toe and shoulder. Embodiments of the disclosure relate toorthopedic drill bits used for forming bone cavities.

BACKGROUND

General Background

Pain and overuse disorders of the joints of the body is a commonproblem. For instance, one of the most important joints which are liableto wearing and disease is the knee. The knee provides support andmobility and is the largest and strongest joint in the body. Pain in theknee can be caused by for example injury, arthritis or infection. Theweight-bearing and articulating surfaces of the knees, and of otherjoints, are covered with a layer of soft tissue that typically comprisesa significant amount of hyaline cartilage. The friction between thecartilage and the surrounding parts of the joint is very low, whichfacilitates movement of the joints under high pressure. The cartilage ishowever prone to damage due to disease, injury or chronic wear. Moreoverit does not readily heal after damages, as opposed to other connectivetissue, and if healed the durable hyaline cartilage is often replaced byless durable fibrocartilage. This means that damages of the cartilagegradually become worse. Along with injury/disease comes a problem withpain which results in handicap and loss of function. It is thereforeimportant to have efficient means and methods for repairing damagedcartilage in knee joints.

Today's knee prostheses are successful in relieving pain but there is alimit in the lifetime of the prostheses of 10-15 years. The surgicaloperation is demanding and the convalescence time is often around 6-12months. In many cases today, surgery is avoided if training andpainkillers can reduce the pain. Prostheses are therefore foremost forelderly patients in great pain, at the end of the disease process; atotally destroyed joint. There are different kinds of prostheses, suchas half prosthesis, total prosthesis and revision knee, the latter usedafter a prosthesis failure. The materials used in today's kneeprostheses are often a combination of a metal and a polymeric material,but other materials such as ceramics have also been used. The size ofknee prostheses makes it necessary to insert them through open surgery.

Other attempts practiced at various clinics around the world with themain objective to repair or rebuild cartilage include biologicalapproaches such as micro fractures, cartilage cell transplantation(ACI), periost flap, and mosaic plasty surgery. In mosaicplasty surgerygrafts, in the form of plugs or dowels of healthy cartilage andunderlying bone are harvested from nonbearing parts of the join, i.eareas of low stress in the joint. Such plugs may be denotedosteochondral plugs. In related surgical techniques similarly shapedplugs as those of mosaicplasty, but made of artificial material, may beused. The plugs or dowels are inserted into drill holes made at thediseased or damaged site, such that they form a mosaic pattern ofhealthy cartilage at the surface of the joint. Osteochondral autografttransfer (OATS) is a technique similar to mosaicplasty but during theOATS procedure the plugs are usually larger, and therefore only one ortwo plugs are needed to fill the area of cartilage damage. A difficultywith both mosaicplasty and OATS is to make sure that the plugs areinserted such that they form an even surface. If the plugs are offsetfrom their intended position, e.g. such that they are tilted or projectover the surrounding cartilage tissue, it may cause increased wear andload on the joint, resulting in more pain for the patient. Thebiological treatments have shown only limited results this far, withimplications such as high cost, risk of infection, risk of loosening,limited suitability for patients of different ages and the extent andlocation of damage. They do however have many advantages, especially foryoung patients who still are growing and who have better abilities forself-repair, if these difficulties can be overcome.

The advantages of implants have stimulated a further development ofsmaller implants that can be implanted with less invasive surgery. Inthis development there has also been an effort to achieve small jointimplants, suitable for repair of a small cartilage injury that have aminimal influence on the surrounding parts of the joint. In the currentdevelopment, such small implants are designed with an implant body thatmay be formed as a thin plate with a hard surface for facing thearticulate side of the joint and a bone contacting surface for facingthe bone below the damaged part of cartilage. The shape and thecurvature of the articulate surface of the implant may be designed to besimilar to the shape and the curvature of the part of the joint wherethe implant is inserted. Such implants are designed as mushrooms with animplant body or head and optionally with a peg or a rod projecting fromthe bone contacting side of the implant body for fastening the implantto the bone.

In the surgical operation of implanting small implants, includinggrafted plugs or artificial plugs used for mosaicplasty or OATS, it iscritical that the implant is positioned in a precise manner. If theimplant is offset from its intended position it may cause increased wearor load on the joint. For example, if the implant is tilted this mayresult in an edge that projects above the cartilage surface and causeswear on the opposing cartilage in the joint. Another example is when theimplant is placed in a position with the surface of the implantprojecting above the surface of the cartilage causing the joint toarticulate in an uneven manner and increasing the load on an opposingpoint of the joint. For the patient, also small misplacements ordeviations from an ideal position may result in pain, longer time forconvalescence or even a surgical operation being done in vain and makingit more difficult to repair the damage in the joint. A large burden istherefore placed on the surgeon not to misplace or misfit the implant.In order to support the surgeon during the implant surgery and toimprove the positioning of the implant various tools and guides thatsupport the surgical procedure have been developed.

Specific Background

During cartilage repair in a joint, different methods are known todayfor repair of cartilage damages. One example is replacing damagedcartilage and thereby repairing a part, namely the damaged part, of thecartilage in the joint instead of replacing the whole joint. Thismethod, replacing a part of the cartilage in the joint using an implant,requires high precision tools. During such a repair it is important thatthe replacement is well fitted in the joint otherwise the implant willstart to move and the repair in the joint will not last for long. Theinstruments on the market today are not user friendly and require muchskills of the surgeon. Several instruments are needed for forming arecess for an implant and may lead to that there is lack of fit for theimplant due to the several steps needed for making a recess. There is aneed for improved instrumentation during these sorts of cartilagerepairs. Improved instrumentation which is easy to use, and which givesthe same result without dependence on which surgeon who is using them.It is also important that the instruments allow for short implantationprocedures.

Some of the surgical tools developed for implant surgery include guidetools having a channel or similar through which the surgical toolsand/or the implant are guided throughout the surgery. Often these guidetools are rather bulky and placed over the damaged site of the cartilagesuch that it is difficult for the surgeon to see the site ofimplantation during surgery. Also it may be difficult to remove debrisand waste that is generated at the implantation site during surgery. Inorder for the surgeon to be able to inspect the implantation site and/orremove such surgery the guide tool has to be removed from the surgicalsite in the joint. There is a need for a surgical kit for replacement orrepair of damaged cartilage at an articular surface in a joint thatguides the surgeon, improves the positioning of the implant or thegrated or artificial plugs used for mosaicplasty or OATS, and thatfacilitates inspection of the implantation site and removal of debrisduring surgery.

Prior Art

Examples of prior art disclosing smaller implants and tools forreplacement of damaged cartilage are shown in:

WO2007/014164 A2 describes a kit comprising a plurality of small jointimplants having different predetermined shapes described as circular,oval, L-shaped and triangular and tools for placing the implants and amethod for placing the implant in a joint, e.g. in the knee or otherjoints where there is a need for repair of a cartilage and/or bonedamage. In this piece of prior art each implant shape has a specificguide tool which corresponds to the shape of the implant.

The cartilage damage is repaired by choosing the most suitable implantfrom the different shapes mentioned above. The corresponding guide toolis selected and is used for faster reaming of the area where the implantis to be placed. A drill is used for drilling a hole to accept the postextending from the bone contacting side of the implant. In the end, theimplant is placed on the area reamed or drilled out for the implant.Although it is the intention that the guide tool shall be used for thepreparation of the placement of the implant it is also said that the useof the guide tool is optional, see passage sections [019, 020].

US20030216669 A1 Shows methods and compositions for producing articularrepair material used for repairing an articular surface. The method fordesigning an articular implant comprises; taking an image of the joint,reconstructing dimensions of the diseased cartilage surface tocorrespond to normal cartilage and designing the medical implantaccordingly. This prior art also shows a surgical assistance device orsurgical tool for preparing the joint to receive an implant. Thesurgical tool comprises of one or more surfaces or members that conformto the shape of the articular surfaces of the joint. It can includeapertures, slots and/or holes that can accommodate surgical instrumentssuch as drills and saws. (see claim 18, [0029], [175] FIG. 13, 15, 16),and thus may also be designed and used to control drill alignment, depthand width, for example when preparing a site to receive an implant[0179]. The tool may be single-use or reusable [181]. These surgicaltools (devices) can also be used to remove an area of diseased cartilageand underlying bone or an area slightly larger than the diseasedcartilage and underlying bone [0182].

EP 1 698 307 A1 discloses an instrument for removing cartilage andintroducing an implantable nonwowen into cartilage. The instrument mayfurther comprise a cartilage puncher having a channel through whichfurther instruments, such as surgical spoons or curettes, can be guidedto the cartilage defect ([0028-0029]).

WO2008098061 A2 also shows examples of small articular surface implantsand tools for placement of the implants. The tools and the implant areused to repair damaged articular cartilage areas.

WO2006091686 A2 Shows a small implant for replacing a portion of anarticular surface (see the abstract). The implant is placed using arotating excision tool (see page 8 line 25) and the implant is selectedfrom a set (see page 10 line 22-23).

WO 2009111626 Shows implants for altering wear patterns of articularsurfaces of joints (see [00190]) and a device and a method for repair ofarticular surfaces, in for example a knee. The implants and methods mayreplace all or a portion of the articular surface and achieve ananatomic or near anatomic fit with the surrounding structures andtissues, the techniques described herein allow for the customization ofthe implant to suit a particular subject, the implant is a mirror imageof the articular surface, see[0057]-[0058]. The implants are selectedfrom predetermined shaped and their location can be optimized for thepatients wear pattern and the wear patterns are assessed by for exampleMRI [0061]-[0063], [0072]. The tools used for placement of the implantsare selected depending on MRI images but not created depending on theimages [00211].

WO2008101090 A2 shows a method for making a large implant suitable for ajoint. The 3D surface of the joint implant is determined using MRI or CTdepicting the damaged that is to be repaired.

US2006/0198877 A1 shows a medical instrument for autologous chondrocytetransplantation.

WO2009/108591 A1 shows a method and tools for repairing an articularcartilage defect and also an implant.

U.S. Pat. No. 6,306,142B1 shows a system and tools for transplanting abone plug from a donor site to a recipient site.

US 2003/0100947 A1 shows a device for repairing articular cartilagedefects.

EP2389905B1 describes a method for designing a surgical kit comprising adrill bit for drilling. Several instruments are needed for making therecess for an implant comprising an extending post.

OBJECT OF THE DISCLOSURE

General Object

The general object of the disclosure is to solve the problem ofproviding means that aid the implantation of a cartilage replacementimplant, including grafted or artificial plugs used for mosaicplasty orOATS, into the articular surface of a joint, aiding and facilitating thework for the surgeon and improving the positioning of the implant inorder to generate optimal repair of damaged tissue and cause minimumdamage to the surrounding tissue.

The disclosure further seeks to solve the partial problems offacilitating inspection of the implantation site and removal of debrisduring surgery.

A further object of the disclosure is to solve the problem of designingimproved instruments for use during replacement of damaged cartilage.Another object is to provide the design of an implant specific drill bitmakes the surgical operation safer and results in better fittingimplants.

SUMMARY OF THE DISCLOSURE

The present disclosure provides a drill tool for implant surgerycomprising a first drill part 222 having a first, smaller diameter fordrilling a recess for an implant post, a second drill part 220 having asecond, larger diameter for drilling a recess for an implant hat, saidsecond drill part having one or more shape cutting edges 228 and one ormore sharp pre-cutting edges 410 extending beyond said one or more shapecutting edges 228. In embodiments, at least one of the one or more sharppre-cutting edges extend beyond the implant hat, in order to provide agap under the implant. In embodiments, at least one of the one or moreshape cutting edges 228 comprises a protruding flange 320. Inembodiments, the protruding flange 320 protrudes from the shape cuttingedge surface 228 with a length 324 of approximately 0.3-3 mm and a width326 of 0.3-1.5 mm or 0.3-2 mm.

The pre-cutting edge 410 may e.g. have a length 224 of 0.3-3 mmprotruding from the shape cutting edge 228 and/or a width 225 of 0.3-2.0mm or 0.3-2.0 mm. The angle 328 between the shape cutting edge 228 andthe longitudinal y-axis 270 of the implant specific drill bit 202 maye.g. be designed to be 90° or less or e.g. 80° or less or 70° or less.

The present disclosure further provides an implant specific drill bit202 comprising:

a drill and bone remover body 220 having a proximal end and a distal endand a longitudinal axis extending between the proximal end and thedistal end;

a bone remover part 226 located in one end of the bone remover body 220;and

a central drill part 222 protruding from said bone remover part 226;

wherein said bone remover part 226 comprises one or more shape cuttingedges 228 placed peripherally around the central drill part 222, whereinsaid one or more shape cutting edges 228 comprises one or more sharppre-cutting edges extending beyond said one or more shape cutting edges.

In embodiments, the one or more shape cutting edges 228 comprise a flatsurface or a surface which further comprises flanges 320.

The present disclosure further provides a modular surgical kitcomprising a guide base and a guide body for use with a set of tools anda method for replacing a portion, e.g. diseased area and/or areaslightly larger than disease area, of a joint, e.g. cartilage and/orbone, with an implant or with one or more artificial or grafted bone andcartilage plugs, such as those used for mosaicplasty or OATS. Themodular surgical kit may also comprise the set of tools. The modularsurgical kit is arranged to achieve a near anatomic fit of the implantwith the surrounding structures and tissues as well as facilitating tosurgical procedure.

The present disclosure further provides a modular surgical kit forrepair of diseased cartilage at an articulating surface of a joint. Itis for use with a medical implant, a grafted plug, or an artificial plugthat has an implant body with a predetermined cross-sectional profile.The modular surgical kit comprises a guide base with a positioning bodyand a guide hole through the positioning body. The positioning body hasa cartilage contact surface that is designed to fit the contour ofcartilage or subchondral bone in the joint in a predetermined areasurrounding the site of diseased cartilage. The guide hole has a muzzleon the cartilage contact surface at a position corresponding to the siteof the diseased cartilage.

The modular surgical kit further comprises a guide body with a guidechannel. The guide channel has a cross-sectional profile that isdesigned to correspond to the cross-sectional profile of the implantbody and also has a muzzle.

Furthermore, the guide base, e.g. the positioning body comprises meansfor releasably connecting to the guide body. When connected, the guidechannel is positioned in relation to the positioning body such that itsmuzzle emanates at a site corresponding to the site of implantation intothe bone.

In one embodiment of the modular surgical kit the cartilage contactsurface is custom designed to fit the contour of the cartilage orsubchondral bone of a specific patient. In another embodiment thecartilage contact surface is designed to fit the contour of thecartilage or subchondral bone of an average patient.

In one embodiment of the modular surgical kit, for use e.g. inmosaicplasty or OATS surgery, the guide body comprises at least twoguide channels. Each guide channel has a cross-sectional profile that isdesigned to correspond to the respective cross-sectional profile of atleast two implant bodies.

In a further embodiment of the modular surgical kit the guide channel,having a cross-sectional profile that is designed to correspond to thecross-sectional profile of the implant body, is provided by a guideinsert that is designed to fit in the guide body.

In still another embodiment the modular surgical kit further comprises adrill adjustment device that is arranged to enable adjustment of thedrill depth e.g. in certain length intervals.

In one embodiment the positioning body is arranged with at least onebreakage means for enabling easy removal of part of the positioning bodyby tearing, fracturing or similar breakage. Such means may for examplebe provided by grooves, slots or perforations or other weakening of thestructure.

The positioning body may also be arranged with at least one attachmentmeans for enabling easy attachment of adaptors, pins and other devicesused during surgery, e.g. by snap fit. The modular kit may also furthercomprise adaptors that fit the attachment means, for enabling flexibleattachment of pins and other devices.

In one embodiment the modular surgical kit further comprises an inserttool with a cross-sectional profile that is designed to correspond tothe cross-sectional profile of the guide channel, with a toleranceenabling the insert tool to slide within the guide channel.

Such insert tool may be a cartilage cutting tool that has across-sectional profile that is designed to correspond to thecross-sectional profile of the guide channel, with a tolerance enablingthe cartilage cutting tool to slide within the guide channel. Thecartilage cutting tool comprises a cutting blade with sharp cuttingedges that are able to cut the cartilage in a shape that substantiallycorresponds to the cross-section of the implant body.

The insert tool is in another embodiment a drill and bone remover havinga drill and bone remover body with a cross-sectional profile that isdesigned to correspond to the cross-sectional profile of the guidechannel, with a tolerance enabling the drill and bone remover to slidewithin the guide channel. The drill and bone remover may comprise acentral drill, for drilling a bore to receive the extending post of theimplant, and a bone remover, for cutting a recess in the bone to receivethe implant body of the implant.

The insert tool may further be a mandrel having a mandrel surface thatis designed to fit the articulate surface of the implant. The mandrelalso has a cross-sectional profile that is designed to correspond to thecross-sectional profile of the guide channel, with a tolerance enablingthe mandrel to slide within the guide channel.

In one embodiment the surgical kit further comprises an implant dummyhaving an implant element that is designed to match the implant body andhaving a lower surface that is a replica of the bone contact surface ofthe implant, but comprising no extending post. The surgical kit mayfurther comprise a dummy reference that is arranged to fit to, andpossibly releasably attach to, the guide hole of the guide base. It isarranged to receive the implant dummy, by being provided with a channel.

Embodiments provide an implant specific drill bit.

The present disclosure further provides a design method designing animplant specific drill bit 202 comprising steps:

a. determining or selecting a size and shape of an orthopedic implant210 comprising a circular shaped implant body or hat 227 and a centrallyplaced circular shaped extending post 223 protruding from the bonecontacting surface 238 in a longitudinal y-axis 260 direction of theimplant 210; and

b. selecting design parameters for the implant specific drill bit 202by;

-   -   selecting the width 240 of the broadest part of the bone remover        226 in a side view to correspond to, or to be slightly smaller        than, the diameter 250 of the implant body or hat 227 of the        specific implant 210 that is to be implanted;    -   selecting the rotational volume and the length 272 of the        central drill part 222 to correspond to, or to be slightly        smaller than, the diameter of the extending post 223 of the        specific implant 210 that is to be implanted;    -   selecting the curvature of the one or more shape cutting edges        228 that is placed anywhere peripherally around or surrounding        the central drill part 222 of the implant specific drill bit 202        to correspond to the curvature of the bone contacting surface        238 of the implant.

In embodiments, the selection of design parameters for the implantspecific drill bit 202 further comprises adding one or more sharppre-cutting edges 410, 414 extending beyond said one or more shapecutting edges 228.

In embodiments, the one or more sharp pre-cutting edges 410, 414 aredesigned to extend beyond the implant hat 227, in order to provide a gapunder the implant hat 227.

In one embodiment the design method according to the present disclosurefor designing the implant specific drill bit comprises determining thesize and shape of said implant so that it may either be performed by:

-   -   selecting implants from a kit of implants of different        predetermined sizes; or    -   by individually designing the size and shape of an implant;

wherein the size and shape of the selected implant is corresponding inlarge or partly or substantially to the size and shape of a cartilagedamage in a specific patient.

A design method according to any of the preceding claims wherein saidshape cutting edge 228 in side view is designed to correspond to theshape of at least one side of the bone contacting surface 238 in across-sectional view of the specific implant 210; and wherein the bonecontacting surface (38) is substantially flat or a bone contactingsurface 238 which comprises an protruding anchoring ring portion 236.

In embodiments, the selection of design parameters for the implantspecific drill bit 202 further comprises providing the shape cuttingedge 228 with at least one protruding flange 320 corresponding to aprotruding anchoring ring portion 236.

Further varieties of the design method according to the disclosurecomprising any of the following optional, individual or combinableaspects.

A design method wherein the volume of the part of the designed implantspecific drill bit 202 which corresponds to fit the implant 210 is0.1-5% smaller than the volume of the implant (10) to be implanted,allowing for press fit of the implant 210 placed in the recess made bythe implant specific drill bit 202 according to the disclosure.

A design method wherein the cutting edge comprises at least one flange320.

A design method wherein the flange has a length 224 of 0.3-3 mmprotruding from the shape cutting edge 228 and/or a width 225 of 0.3-2.0mm or 0.3-2.0 mm corresponding to the length 235 in a cross-sectionalview of the anchoring ring portion 236 of an implant 210.

A design method wherein the angle 328 between the shape cutting edge 228and the longitudinal y-axis 270 of the implant specific drill bit 202 isdesigned to be 90° or less or for example 80° or less or 70° or lessbased on the selected specific implant and its corresponding angle.

A design method wherein the length 272 of the central drill part 222 ofthe implant specific drill bit is designed to be 2-300 mm correspondingto or slightly longer, or 1-5% longer than the length 282 of theextending post 223 of an specific implant 210.

An implant specific drill bit 202 made due to the design method used fordesigning the product for producing bone cavities for receivingorthopedic implants according to the disclosure wherein, said drill bit202 comprises:

a drill and bone remover body 220 having a proximal end and a distal endand a longitudinal axis extending between the proximal end and thedistal end; and

a bone remover part 226 located in one end of the bone remover body 220;and

a central drill part 222 protruding from said bone remover part 226;

wherein said bone remover part 226 comprises one or more shape cuttingedges 228 placed peripherally around the central drill part 222, whereinsaid one or more shape cutting edges (228) comprises one or more sharppre-cutting edges (410, 414) extending beyond said one or more shapecutting edges (228).

An implant specific drill bit 202 wherein the bone remover part 226comprises a flat surface or a surface which further comprises flanges320.

A kit comprising an implant specific drill bit 202 and an implant 210,wherein said implant specific drill bit 202 is designed according to anyone of the design methods described above to correspond to the size andshape of said implant 210.

A implant specific drill bit 202 or a drill and bone remover 202according to the disclosure that is used to drill a hole in the bone atthe site of cartilage damage, for fastening of the extending post 223 ofthe implant 210 in the bone tissue, and simultaneously create a recessin the bone tissue at the site where the implant body 227 is to bereceived. The drill and bone remover 202 comprises a drill and boneremover body 220, a central drill 222 and a bone remover 226. Thecentral drill 222 extends from the center of the drill and bone removerbody 220, i.e. corresponding to the position of a centrally placedextending post 223 on an implant 210 having a circular implant body 227.The diameter of the central drill 222 is the same as, or slightlysmaller than, the diameter of the extending post 223 of the implant 210that is to be implanted. The bone remover 226 has a cutting edge that isplaced peripherally around the central drill 222. The diameter of thebone remover 226 is the same as, or slightly smaller than, the diameterof the implant body 227 of the implant 210 that is to be implanted, thuscreating a recess that matches the implant body, in which the implantbody can be received. The cutting edge of the bone remover 226 is hardenough for cutting or carving bone. It may be made of materials such asstainless steel.

The drill and bone remover body 220 may be designed to fit the inside ofthe guide channel of the guide body of a guide tool, with a slighttolerance to allow a sliding movement of the drill and bone remover 202in the guide channel. In other words, the cross-sectional profile of thedrill and bone remover body 220 matches the cross-sectional profile ofthe guide channel as well as the of the implant 210. The fit ensures thecorrect, desired placement of the drill and bone remover 202 on thecartilage surface and thus ensures the precise direction and placementof the drill hole for the extending post 223, as well as the recess forthe implant body 227, in the bone.

The drill and bone remover 202 may also be equipped with a depth gauge207. The depth gauge 207 of the drill and bone remover determines thedepth of the created drill hole as well as the recess for the implantbody 227. The depth gauge 207 has a cross-sectional profile that islarger than the cross sectional profile of the guide channel. The depthgauge 207 will, during the surgical procedure, rest against the top ofthe guide body and/or drill adjustment device 16, thus preventing thedrill and bone remover 202 to drill/carve/cut deeper into the bone. Thedistance between the tip of the cutting edge of the cutter and the depthgauge 207, and the relation between that distance and the length of theguide channel, will determine the depth that the is allowed to go intothe cartilage and/or bone. The depth gauge 207 may be arranged such thatthat distance is adjustable. In a more preferred embodiment the distanceis fixed and instead the drill/cut/carve depth is adjusted by adjustingthe length 31 through the drill adjustment device 16.

BRIEF DESCRIPTION OF THE FIGURES

The present disclosure will be further explained below with reference tothe accompanying drawings, in which:

FIG. 1 shows a schematic overview of an exemplifying method used fordesigning a patient specific surgical kit.

FIG. 2 shows a surgical kit according to one embodiment, exemplified bya surgical kit for a knee, the surgical kit comprising a guide base, aguide body and a set of tools.

FIGS. 3a-b shows an exemplifying embodiment of an implant.

FIGS. 3c-f show exemplifying cross-sectional profiles of such implant.

FIGS. 4a-b show an exemplifying embodiment of a grafted plug.

FIGS. 4c-f show exemplifying cross-sectional profiles of such graftedplug.

FIGS. 4g-h show such grafted plugs implanted into bone by use ofmosaicplasty surgery.

FIG. 5a-d show exemplifying embodiments of a guide base, for use in aknee joint (a-b) and in a toe joint (c-d) respectively.

FIG. 6 shows an exemplifying embodiment of a modular surgical kit, furuse in a knee joint.

FIG. 7 shows an exemplifying embodiment of a modular surgical kit, furuse in a toe joint.

FIG. 8 shows an exemplifying embodiment of a guide body, for use inmosaicplasty surgery.

FIG. 9 shows an exemplifying embodiment of a cartilage cutter.

FIG. 10 shows an exemplifying embodiment of a drill and bone remover.

FIG. 11a shows an exemplifying embodiment of a dummy reference.

FIG. 11b and an implant dummy.

FIG. 12 shows an exemplifying embodiment of a mandrel.

FIGS. 13a -1 show exemplifying embodiments of the cross-sectionalprofiles of an implant and tools of the modular surgical kit.

FIG. 14a-t show an exemplifying embodiment of a method for implanting acartilage implant using the modular surgical kit of the presentdisclosure.

FIG. 15 schematically illustrates an implant specific drill bitaccording to an exemplified embodiment.

FIG. 16a schematically illustrates an implant specific drill bitaccording to an exemplified embodiment.

FIG. 16b schematically illustrates an implant for implantation accordingto an exemplified embodiment.

FIG. 17 schematically illustrates use of an implant specific drill bitfor creation of a recess in a joint.

FIG. 18a schematically illustrates an implant specific drill bitaccording to an exemplified embodiment.

FIG. 18b schematically illustrates an implant for implantation accordingto an exemplified embodiment.

FIG. 19a schematically illustrates an implant specific drill bitaccording to an exemplified embodiment.

FIG. 19b schematically illustrates an implant for implantation accordingto an exemplified embodiment.

FIG. 20a shows an exemplified embodiment of an implant specific drillbit comprising a cutting edge on only one side of the longitudinaly-axis of the drill bit and having the rotational volume correspondingto the specific implant.

FIG. 20b schematically illustrates an implant for implantation accordingto an exemplified embodiment.

FIG. 20c shows a perspective view of the implant in FIG. 20 b.

FIG. 21 shows an example of a recess in cartilage and bone tissuedrilled with conventional drilling tools having frayed cartilage andmisaligned cartilage and bone tissue recesses.

FIG. 22 shows an example of two adjacent recesses drilled with drilltools of embodiments drill tools presented herein.

FIG. 23 shows an embodiment of a drill tool with sharp pre-cutting edgesand shark fin shape forming edges.

FIGS. 24a and 24b show images of an embodiment of a drill tool withsharp pre-cutting edges and shark fin shape forming edges.

FIGS. 25a and 25b illustrate an embodiment of a drill tool and implant,and show the corresponding shapes of the lower part of the drill tooland the bone contacting part of an implant.

DETAILED DESCRIPTION

Introduction

This disclosure concerns a surgical kit for use in orthopedic surgery. Asurgical kit according to the disclosure comprises a set of tools forthe implantation of an implant, or one or more grafted plugs orartificial plugs that replaces damaged cartilage in a joint.

FIG. 2 shows a surgical kit according to one embodiment of the presentdisclosure, for use in repair of damaged cartilage in a knee joint. Thesurgical kit comprises tools that are adapted to an implant and to ajoint; a guide base 12 with a positioning body 11 and, releasablyattached thereto, a guide body 13. A drill adjustment device 16 fittingto the guide body 13 may also be included in the kit. Further thesurgical kit may comprise insert tools, for example a cartilage cuttingtool 3: a drill 2, in this exemplifying embodiment equipped also with abone remover 26, an implant dummy 36, a dummy reference 37 and/or amandrel 35. Optionally, the kit may also comprise the implant to beimplanted by use of the surgical kit.

The implant and the set of tools according to the disclosure arepreferably individually designed for a person's joint. The implant andthe set of tools are also optionally individually designed for aspecific person's cartilage individual injury.

Exemplifying embodiments of the disclosure are shown herein which areespecially adapted for cartilage replacement at the femur of a kneejoint and at the joint of a toe. The disclosure may however, also haveother useful applications, such as for cartilage replacement at anarticulating surface at any other joint in the body, e.g. elbow, ankle,finger, hip and shoulder.

The Surgical Kit

This disclosure provides a surgical kit where the successful implantinsertion is less depending on the skills of the surgeon compared topreviously known methods and which facilitates inspection of thesurgical procedure as well as removal of wear and debris during thesurgery. This disclosure provides preferably individually designed toolsand implant. Due to the design and the function of both tools andimplant the surgical kit gives improved implantation precision and aprecise desired placement of the implant in the joint every time. Theprecision of the surgery is “built in” into the design of the tools.

The surgical kit of the disclosure leads to shorter learning curves forthe surgeon since the surgical kit facilitates for quick, simple andreproducible surgery.

In one exemplifying embodiment the implant is intended for replacingdamaged cartilage in a knee. The site where the implant is to beimplanted according to the disclosure is an articular cartilage surfaceincluding, for example, the lateral femoral chondral (LFC) surfaces,medial femoral chondral (MFC) surfaces, trochlea surfaces, patellasurfaces, tibia surfaces (e.g. surfaces of the tuberosities of thetibia), and combinations and portions thereof. For example implants maybe placed on any one of these surfaces.

In another exemplifying embodiment the implant is intended for replacingdamaged cartilage in a toe, for example on the cartilage surfacesbetween the metatarsals and the proximal phalanges bones in a toe.

In a further exemplifying embodiment the implant is intended forreplacing damaged cartilage in a shoulder, for example on thearticulation surfaces between the head of the humerus and the lateralscapula (specifically—the glenoid fossa of the scapula).

The implant is inserted through a small open surgery operation using atool kit where the tools in the tool kits are preferably individuallydesigned or tailor/custom made for the person who suffers from theinjury. This leads to decreased suffering of the patient and iseconomically favorable since it leads to shorter convalescence time andless time for the patient at the hospital. By using this optionallyindividually designed surgery kit the implant insertion will be optimaland thus misalignment which is one of the problems associated with thecommon methods used today can be avoided.

Using the surgical kit according to the disclosure, small cartilagedamages will require small implants and in this way combined with thedesign of the guide tool, a surgical operation with little tissuedamage, a small open surgery, is needed for the person suffering from aknee injury. This gives the effect that minimal modifications on theunderlying bone and surrounding tissue are required when preparing forthe implant surgery. Using implants according to the present disclosuremakes it possible to repair cartilage defects at a much earlier stagethan previously. This early replacement of damaged cartilage maypostpone or prevent osteoarthritis.

The object of the disclosure is to solve the problem of repairingdamaged, injured or diseased cartilage in knees, toes, elbows orshoulders by providing an implant that will have better placement andthus a seamless placement in the cartilage.

The benefits from the implant according to the disclosure are relieffrom pain and swelling in the joint and also the restoration of asmooth, continuous articulating surface. The implant and the tool kit ofthe present disclosure also facilitates for the return to normalactivity with rapid recovery time, possibility to postpone or avoidtotal knee replacement surgery. A less traumatic surgery procedure isused and potentially faster recovery after surgery.

Implants

The surgical kit of the present disclosure may be used for implantationof for example small implants and of bone and cartilage plugs, such asosteochondral plugs, or artificial plugs used in mosaicplasty or OATS.Examples of implants to be used with the surgical kit of the disclosurewill be given below. The kit may however be used with any implant havingan implant body with a cross-sectional profile that corresponds to thecross-sectional profile the guide channel of the guide body 13 (seebelow).

Small Implant

FIGS. 3a-3b shows an embodiment of a medical implant 10 that may be usedwith a surgical kit according to the present disclosure. The implantcomprises an implant body 27 and an extending post 23. The implant body27 has an articulate surface (first surface) 15 configured to face thearticulating part of the joint and a bone contact surface (secondsurface) 21 configured to face bone structure in the joint. An extendingpost 23 extends from the bone contact surface 21. Between the articulatesurface 15 and the bone contact surface 21 there is a cartilagecontacting surface 19.

The implant may be specially designed, depending on the appearance ofthe knee and the shape of the damage and in order to resemble the body'sown parts, having a surface which preferably corresponds to a threedimensional (3D) image of a simulated healthy cartilage surface. Theimplant can thus be tailor-made to fit each patient's damaged part ofthe joint. Alternatively, the implant to may be of standard shapes andsizes.

Implant Body

The implant body 27 is in one embodiment substantially plate shaped,meaning that the shortest distance (represented by 24 in FIG. 3a )crossing the surface 15 of the implant body 27 is substantially larger,e.g. at least 1.5 times larger than the thickness 14 of the implant body27. By substantially plate shaped is meant that the implant body 27 maybe substantially flat or may have some curvature, preferably a 3Dcurvature of the articulate surface 15. The plate shaped implant body 27has a cross-section 81 that substantially corresponds to the area of thedamaged cartilage, see FIGS. 3c-f and 13a -1 implant 10, with fourexemplifying cross-sectional views, 81 a-d. The articulate surface 15 ofthe plate shaped implant body 27 may have a curvature that substantiallycorresponds to the curvature of a healthy articulating surface at thesite of diseased cartilage. The curvature may for instance correspond toa simulated healthy cartilage reconstructed from an image taken with MRIimage or the CT-scanning of the damaged cartilage surface of the joint.Once the implant 10 is placed in the joint there will be a surface withno parts of the implant pointing up from or down below the surroundingcartilage—the implant is incorporated to give a smooth surface.

The size and the shape of the implant body 27 may be individuallyadapted, or may be chosen from a set of standards, dependent on the sizeof cartilage damage and location of the cartilage damage. The area andshape of the implant can be decided by the surgeon himself or be chosenfrom predetermined shapes. For instance the cross-section of the implantbody 27 may have a circular or roughly circular, oval, triangular,square or irregular shape, preferably a shape without sharp edges (seee.g. FIGS. 3c-f and 13a -1, implant 10). The size of the implant 10 mayalso vary. The area of the articulate surface 15 of the implant variesin different realizations between 0.5 cm² and 20 cm², between 0.5 cm²and 15 cm², between 0.5 cm² and 10 cm², between 1 cm² and 5 cm² orpreferably between about 0.5 cm² and 5 cm².

In general, small implants are preferred since they have a smallerimpact on the joint at the site of incision and are also more easilyimplanted using arthroscopy or smaller open surgical procedures. Theprimary factor for determining the size of the implant is however thenature of the lesion to be repaired.

The articulate surface 15 of the implant body 27, and the core of theimplant body 27, comprises a biocompatible metal, metal alloy orceramic. More specifically it can comprise any metal or metal alloy usedfor structural applications in the human or animal body, such asstainless steel, cobalt-based alloys, chrome-based alloys,titanium-based alloys, pure titanium, zirconium-based alloys, tantalum,niobium and precious metals and their alloys. If a ceramic is used asthe biocompatible material, it can be a biocompatible ceramic such asaluminium oxide, silicon nitride or yttria-stabilized zirconia.Preferably the articulate surface 15 comprises a cobalt chrome alloy(CoCr) or stainless steel, diamond-like carbon or a ceramic. Thearticulate surface 15 and the core of the implant body 27 may comprisethe same or different materials.

The articulate surface 15 may also be further surface treated in orderto e.g. achieve an even more durable surface or a surface with a lowerfriction coefficient. Such treatments may include, for example,polishing, heat treatment, precipitation hardening or depositing asuitable surface coating.

The Bone Contact Surface

The implant body 27 has a bone contact surface (bone contact surface)21, configured to face or contact the bone structure of the joint. Inone embodiment the bone contact surface 21 comprises a biocompatiblemetal, metal alloy or ceramic, such as any of the metals, metal alloysor ceramic described above for the articulate surface 15. Preferably thebone contact surface 21 comprises a cobalt chrome alloy (CoCr), atitanium alloy, titanium or stainless steel.

In one embodiment the bone contact surface 21 comprises, or in onespecific embodiment is coated with, a bioactive material. In analternative embodiment, the bone contact surface does not comprise abioactive material and/or is uncoated.

The bioactive material of the bone contact surface, if present,preferably stimulates bone to grow into or onto the implant surface.Several bioactive materials that have a stimulating effect on bonegrowth are known and have been used to promote adherence betweenimplants and bone. Examples of such prior art bioactive materialsinclude bioactive glass, bioactive ceramics and biomolecules such ascollagens, fibronectin, osteonectin and various growth factors. Acommonly used bioactive material in the field of implant technology isthe bioactive ceramic hydroxyapatite (HA), chemical formulaCa₁₀(PO₄)₆(OH)₂. HA is the major mineral constituent of bone and is ableto slowly bond with bone in vivo. HA coatings have been developed formedical implants to promote bone attachment. Another bioactive materialcommonly used in prior art is bioactive glass. Bioactive glasses,generally comprising SiO₂, CaSiO₃, P₂O₅, Na₂O and/or CaO and possiblyother metal oxides or fluorides, are able to stimulate bone growthfaster than HA.

The bioactive materials described above have an anabolic effect on thebone i.e. stimulates bone growth. The fixation of the implant can alsobe improved by decreasing the catabolic processes i.e. decrease theamount of bone resorption next to the implant. The bone contact surface21 and/or the extending post can also be modified with bisphosphonates.Bisphosphonates are substances that decrease the catabolic process ofbone and binds readily to HA. One way to bind the bisphosphonate to thesurface is by coating it with HA, which it readily binds to. The implantcan also simply be immersed in a bisphosphonate solution or linked withsome other biocompatible molecule e.g. carbodiimides,N-hydroxysuccinimide (NHS)-esters, fibrinogen, collagen etc.

In one embodiment the bone contact surface 21 is coated with a doublecoating. Such double coating may for instance comprise an inner coatingcomprising titanium (Ti). The second, outer coating, that is configuredto contact the cartilage and or bone, is preferably a hydroxyapatiteand/or beta tricalcium phosphate (TCP) coating containing more than 95%hydroxyl apatite or 95-99.5% hydroxyapatite. By this design even morelong-term fixation of the implant is achieved, since bone in- oron-growth to the implant is further stimulated by the titanium, even ifthe more brittle hyroxyapatite would eventually shed/dissolve.

The bone contact surface may also be further modified with fluorocompounds or acid etching to enhance the bioactivity and theosseointegration of the surface. Another method to facilitateosseointegration is blasting of the bone contact surface.

The Extending Post

The implant replaces an area of damaged cartilage in an articulatingsurface of a joint. Before the implant is placed in the desiredposition, the damaged cartilage is removed and also a part of the bonebeneath. Furthermore, a hole can be drilled to fit the implantstructure. An extending post or rod-part 23 of the implant 10 (see FIGS.3a-b ), may be used for securing the implant 10 in the drilled hole ofthe bone. The length of the extending post 23, extending from the bonecontact surface 21, is adjusted to a length needed to secure the implant10 in the bone. The extending post 23 is intended to give a primaryfixation of the implant 10; it provides mechanical attachment of theimplant 10 to the bone in immediate connection with the surgicaloperation.

The position of the extending post 23 on the bone contact surface 21 canbe anywhere on the bone contact surface 21 or the extending post 23 mayhave a central position.

The extending post 23 has a physical structure in the form of forexample a cylinder or other shapes such as one or more of a small screw,peg, keel, barb or the like.

The extending post 23 can in one embodiment be coated with a bioactivematerial, for example a bone stimulating material with single or doublecoatings and/or, a substance inhibiting bone resorption such asdescribed for the bone contact surface 21 above. The surface of theextending post can also be further modified using e.g. fluoro compoundsor acid etching or blasting, to enhance osseointegration of the surface.

In another embodiment, the extending post 23 is uncoated and theextending post may comprise e.g. a metal, metal alloy or ceramicmaterial, such as the metal, metal alloys or ceramic materials describedfor the articulate surface 15 above.

In one embodiment, as exemplified in FIGS. 3a-b , the extending post 23has a positioning part 25, where the positioning part 25 is locateddistal to the plate shaped implant body 27. The longitudinal symmetryaxes of the first part of the extending post 23 and the positioning part25 coincide. The diameter of the positioning part 25 is smaller than thediameter of the first part of the extending post 23.

Grafted Plug or Artificial Plug

In an alternative embodiment the surgical kit of the present disclosuremay be used for mosaicplasty or osteochondral autograft transfer (OATS).In such case the implant to be used with the surgical kit does not havea plate shaped implant body with extending post, but rather is a graftedplug taken from healthy bone and cartilage, see FIGS. 4a-b , or anartificial plug, having the same general shape as a grafted plug butbeing made of an artificial material (see below). FIG. 4a shows agrafted plug 600 in the form of a bone and cartilage plug, such as aosteochondral plug, that has been harvested from a nonbearing part of ajoint. The implant body 627 of the grafted plug 600 has a cylindrical toa substantially cylindrical form. By cylindrical to a substantiallycylindrical form is meant a form or shape having parallel side walls,and having a cross-sectional profile 81 that is preferably circular orroughly circular but that may also have any other shape, including oval,triangular, square or irregular shape, preferably a shape without sharpedges, see exemplifying cross-sections 81 a-d in FIGS. 4c-f . At theupper part of the grafted plug 600 there is healthy cartilage 606 fromthe site of harvest, while the lower portion of the grafted plug 600comprises bone tissue.

The grafted plug 600 may be further reshaped after harvesting by using asharpener tool, see FIG. 4b . The sharpener tool may be constructed as apencil sharpener, with a sharp blade, but which may be used to adjustthe shape and/or the length of the bone part of the grafted plug 600, inorder to arrange such that several plugs may fit together in an area ofcartilage damage. The implant body 627, i.e. the upper part of thesharpened grafted plug 600, still has a cylindrical form, as definedabove, i.e. with parallel side walls and a cross-sectional profile 81that can have various shapes.

In another embodiment the plug used for mosaicplasty or OATS may be anartificial plug made of an artificial material such as synthetic polymerscaffolds, e.g. polylactide-co-glycolid, calcium sulfate, polycarbonatepolyurethane or polyglycolide fibers or synthetic calcium. Suchartificial plugs have the same geometrical shapes as the grafted plug600 described above. Importantly for the present disclosure theartificial plug, like grafted plug 600, has an implant body 627 with acylindrical form, that is a form or shape with parallel side walls andwith a cross-sectional profile 81 that is preferably circular or roughlycircular, but that may also have any other shape, including oval,triangular, square or irregular shape, preferably a shape without sharpedges.

An grafted plug 600 or an artificial plug has a cross-sectional areathat is between 0.5 cm² and 5 cm², between 0.5 cm² and 3 cm², orpreferably between about 0.5 cm² and 2 cm² at its cylindrical portion.It has a length 710 that is between 1 and 4 cm, or between 1.5 and 3 cm.The cross-sectional diameter at the cylindrical portion may for examplebe 0.1-1 cm.

FIGS. 4g-h show a cartilage damage site repaired using mosaic repairtechnique, FIG. 4g from a cross-sectional side view of the joint, andFIG. 4h from above. Several grafted plugs 600 have been inserted at thesite of damaged or diseased cartilage, to form a mosaic pattern. FIG. 4halso shows that grafted plugs 600 have been harvested from the healthypart of the joint (right hand side of the figure).

According to an embodiment, the amounts of plugs and also the size andshape of the healthy cartilage and bone plugs are selected depending onthe shape and size of the injury.

The Set of Tools

The set of tools comprises a guide base 12, to which a guide body 13with a guide channel 54 is releasably attached, see FIGS. 5a -7. It mayalso comprise a selection of insert tools, for use when mounting animplant 10, a grafted plug 600 or an artificial plug to the implantsite, see FIGS. 2 and 8-11 b. The insert tools are in operation insertedin the guide channel 54 of the guide body 13 and fits in the guidechannel 54, with a slight tolerance to allow a sliding movement of theinsert tool in the guide channel 54. The cross-sectional profile, andthus the circumferential shape of the insert tools, corresponds to thechosen cross-section 81 of the implant body 27, 627 of the implant 10,grafted plug 600 or artificial plug, in size and shape (see FIGS. 13a-1). The insert tools are in different embodiments provided in the formof for example a cartilage cutting tool, a punch, a drill, a drillguide, a bone cutting tool, a reamer guide and/or a hammer tool. Someinsert tools are used together with further tools such as a drill bitand/or a reamer bit. An exemplifying set of insert tools will bedescribed herein. The modular surgical kit may further be used withother insert tools, such as insert tools disclosed in PCT applicationPCT/EP2011/058473 or European patent application 11163405.1.

Guide Base, Guide Body and Guide Insert

FIG. 6 shows an exemplifying embodiment of a modular surgical kit of thedisclosure, for use in a knee joint. FIG. 7 shows an exemplifyingembodiment of a modular surgical kit, for use in a toe joint. Themodular surgical kit comprises a guide base 12 that is releasablyattached to a guide body 13. FIGS. 5a-d show the guide base 12 in moredetail.

Two embodiments of a guide base 12 for use in a knee joint are shown inFIGS. 5a-b , and one embodiment of a guide base 12 for use in a toejoint is shown in FIGS. 5c-d . In FIGS. 5b and 5d the guide base 12 isplaced on the femoral bone 141 of the knee joint and a falangeal jointbone 142 of a toe respectively. The guide base 12 comprises apositioning body 11 and a guide hole 53, which may alternatively bedenoted guide recess or guide opening or similar, through saidpositioning body 11. The positioning body 11 has a cartilage contactsurface 50 that has a shape and contour that is designed to correspondto and to fit the contour of the cartilage or the subchondral bone inthe joint in a predetermined area surrounding the site of diseasedcartilage. The cartilage contact surface 50 may be adapted to fit to thejoint of an average patient or may be adapted, i.e. custom made, for anindividual patient. The positioning body 11 also has a top surface 52facing the opposite direction compared to the cartilage contactingsurface 50.

The guide hole 53 has a muzzle 29 on the cartilage contact surface 50,at a position of the positioning body 11 that corresponds to the site ofthe diseased cartilage, i.e. the site of implantation. In one embodimentthe guide hole 53 has a cross-sectional profile that is designed tocorrespond to the cross-section 81 of the implant body 27, 627 of theimplant 10, grafted plug 600 or artificial plug to be implanted. Inanother embodiment the guide hole 53 has a cross-section that isslightly larger than the cross-section 81 of the implant body 27, 627.In a further embodiment the cross-sectional profile of the guide hole 53need not correspond to the cross-section 81 of the implant body 27, 627.Where the cross-sectional profile of the guide hole 53 is different fromthe cross-section 81 of the implant body 27, 627, correspondence ormatching to the cross-section 81 of the implant body 27, 627 is providedby the cross-sectional profile of the guide channel 54 of the guide body13 only (see below).

An embodiment of a guide body 13 is shown in FIGS. 6 and 7. The guidebody 13 has a guide channel 54 that extends through the guide body 13.The outer shape and design of the guide body 13 may vary, as isschematically illustrated by a circular design 13 a and a square design13 b in FIGS. 13a-c (implant 10 and guide body 13 a, 13 b seen fromabove). The guide channel 54 of the guide body 13, however, has an innercross-sectional profile (see FIG. 13a -1) that is designed to correspondto the cross-section 81 of the implant body 27, 627. In other words, theimplant body 27, 627 fits the guide channel 54, with a slight toleranceto allow a sliding movement of the implant in the guide channel 54.

In an alternative embodiment the guide body 13 has a guide channel thathas a cross-sectional profile which is larger than the cross-sectionalprofile 81 of the implant body 27, 627. In this case the guide channel54 that is designed to correspond to the cross-section 81 of the implantbody 27, 627 is instead provided by a guide insert 8 (see FIGS. 6 and 7,and top view in FIG. 13a -1). The guide insert 8 is designed to haveouter proportions to make it fit in the guide channel of the guide body13. Its guide channel 54 is designed to have an inner cross-sectionalprofile that corresponds to the cross-section 81 of the implant body 27,627. In other words, the implant body 27, 627 fits the guide channel 54,with a slight tolerance to allow a sliding movement of the implant inthe guide channel 54. In this way the guide insert 8 works as anadapter, such that a guide body 13 with a guide channel of a certainsize might be used for implantation of implants of various sizes, by useof guide inserts 8 with varying guide channels 54 that fit implants ofcorresponding varying sizes.

The height 31 of the guide channel 54 must be sufficiently long to givesupport to the tools used inside the guide body 13. The height 31 of theguide channel 54 is preferably also sufficiently high to be easilyaccessible for the surgeon during surgery. In one embodiment, the top ofthe guide channel 54 is designed to project above the tissue surroundingthe surgery cut when the guide tool is placed on the cartilage in ajoint during surgery. The height 31 is preferably higher than thethickness of the surrounding tissue. In this way, the opening of theguide channel 54 is easy to access for the surgeon. The height 31 of theguide channel 54 is between 1 and 10 cm, preferably 3-10 cm and alwayssufficiently high to ensure stabilization of the tools that are to beinserted into the guide channel 54.

FIG. 8 shows an embodiment of a guide body 13, for use in mosaicplastyor OATS surgery. The guide body 13 comprises at least two guide channels54. Each of the guide channels 54 is designed to have a cross-sectionalprofile that corresponds the cross-section 81 of an implant body 627 ofa grafted plug 600 or an artificial plug. The at least two guidechannels 54 may have cross-sectional profiles that are identical.Alternatively their cross-sectional profiles may be different in shapeand/or size/area, depending on the cross-sectional profile 81 of therespective grafted plugs 600 or artificial plugs, that are to beimplanted. Each of the guide channels 54 may also be arranged in theguide body 13 at different angles, depending on the angle in which therespective plugs are to be implanted.

The guide body 13 may be provided with an inspection window 39, i.e. awindow or hole through the side of the guide body 13, into the guidechannel 54, see FIGS. 6 and 7. The inspection window 39 facilitatesinspection of the site of implantation during surgery, also when theguide body 13 is attached to the guide base 12, see FIGS. 14c -h.

The guide base 12 comprises means for releasable attachment 47 to theguide body 13, see FIGS. 5a and b-c and FIG. 6. Such means 47 isarranged such that when the guide body 13 is attached to the guide base12 the guide body 13 extends from the top surface 52 of the guide base12. Such means for releasable attachment 47 is also arranged such that,when attached, the guide channel 54 is positioned in relation to thepositioning body 11 such that its muzzle 32 emanates at a sitecorresponding to the site of implantation into the bone, which is alsoat the site of the guide hole 53. The angle of the guide hole 53 in thepositioning body 11 and the arrangement of the releasable attachmentmeans 47 also determine the angle of the guide channel(s) 54 in relationto the positioning body 11 and implantation site. The guide hole 53and/or the means for releasable attachment 47 are arranged such that,when the guide body 13 is attached to the guide base 12, the angle ofthe guide channel(s) 54 will correspond to the angle in which theimplant 10, grafted plug(s) 600 or artificial plug(s) is/are to beinserted. For small implants 10 the angle of implantation, and thus ofthe guide channel 54, is most often perpendicular to a tangential planeof the site of implantation. For implants 600 used in mosaicplasty orOATS surgery the angle of implantation of the respective plugs, and thusof the respective guide channels 54, may vary.

In one embodiment the cross-sectional profile of the guide hole 53 andthe guide channel 54 correspond and the guide hole 53 and the guidechannel 54 are aligned. That is, the symmetry axis of the guide hole 53and the longitudinal symmetry axis of the guide channel 54 approximatelycoincide. The cross-sectional profile of the guide hole 53 and of theguide channel 54 may in another embodiment be different. Thecross-section of the guide hole 53 must however be at least as big asthe cross-section of the guide channel 54, the cross-section of theguide channel 54 must correspond to the cross-section 81 of the implantbody 27, 627 and the muzzle 32 of the guide channel 54 must emanate at asite corresponding to the site of implantation, when the guide body 13is attached to the guide base 12.

The means for releasable attachment 47 may be provided by a snap fitfunction between the guide base 12 and the guide body 13, and/or by theguide hole 53, or part of the guide hole 53, and the lower part of theguide body 13 being provided with matching threads and/or bayonet mountand/or other form fitting mechanisms. Other releasable attachmentmechanisms are however also conceivable.

The guide base 12 is easy to place due to the precise fit of thepositioning body 11 on the cartilage surface. The guide base 12 isdesigned to be inserted in a lesion which is as small as possible to beable to repair the specific cartilage damage. The size and shape ofcartilage contact surface 50 of the guide base 12 is determineddepending on the size and shape of the damaged cartilage and alsodepending on the position of the cartilage damage in the joint. The sizeand shape of the surface 50 and the positioning body 12 is aconsideration between the following aspects; minimize surgery lesion,maximize stability for the guide base 12, anatomic limitations on thesite of the injury, and that not all cartilage surfaces in a joint canbe used for placement of the guide tool. A large spread of the cartilagecontact surface 50 is to prefer to get good stability of the guide tool,however, a large surface area of the surface 50 may also lead to a largesurgical intervention and this is undesired. Thus the size of thecartilage contact surface 50 and of the positioning body 11 isdetermined by a balance between the desire to achieve good positioningstability and small surgical operations. Also, the cartilage contactsurface 50 does not need to have a continuous, regular shape, but mayhave an irregular shape, as long as it gives adequate support and stablepositioning of the guide base 12.

When designing the guide tool, the cartilage contact surface 50 can bedesigned to cover three points (see FIG. 5b , points 40, 42, 44 for anexample) distributed over the cartilage surface of the joint where theimplant is to be inserted. The points are chosen to give maximum supportand positional stability for the positioning body 11 and thus thesepoints, either decided and identified by the surgeon or automaticallyidentified by design software, serve as the ground when designing thesurface 50 of the guide base 12. The cartilage contact surface 50 canalso be formed such that it uses the curvature in the cartilage surfacein a joint for stability. For example, in a knee joint, the condyles areseparated from each other by a shallow depression, the posteriorintercondyloid fossa, this curvature together with the medial epicondylesurface can be used to give the cartilage contact surface 50 a stabileattachment to the cartilage surface in a knee joint. The surface is inone embodiment a continuous surface covering a selected area surroundingthe cartilage damage. In another embodiment the cartilage contactsurface is distributed over a plurality of points, preferably three ormore of separated contact points. The cartilage contact surface does notneed to be a continuous, regular surface, but preferably has at leastthree points exemplified by 40, 42 and 44 for stability.

Optionally the cartilage contacting surface 50 can be further stabilizedby attachment with nails, rivets or similar attachment means 48 to thebone surrounding the cartilage in a joint (see FIG. 5b ). Thisadditional attachment with rivets or the like gives additional supportand stability and also gives the possibility to keep the cartilagecontact surface as small as possible. The position of the rivets may bepredetermined and marked out on the surface 50 by premade drill holes.

In an alternative embodiment the positioning body 11 may be arrangedwith attachment means 9 for attachment of adaptors 17, pins and possiblyother devices to the guide base 12, see FIGS. 5a, c and d , 6, 7 and 14a-b. Such attachment means 9 may for example connect to the adaptor 17,pin or other device through a snap fit function, thread function or anyother form fitting function. The adaptors 17 shown in FIGS. 6, 7 and 14b have holes or bores that can receive pins, nails, rivets or similarmeans 48 in order to secure the attachment of the guide base 12 to thebone as described above. The elongated form of the adapters 17 allowsuch pins or similar means to be inserted into the bone at a distancefrom the site of implantation. Adaptors of the embodiment shown in FIG.14b also have a shape, i.e. both bent and somewhat elongated, such thatthe pin holes will be both lifted or elevated from the joint surface andsituated at a distance from the site of implantation. This shape isadvantageous since it will be easier to keep the surface of the jointfree of waste and debris from the implantation wound and surroundingsand since it will be possible to insert the pins more straight fromabove. Inserting the pins from at an angle from the side often meansthan the skin around the site of incision has to be more split open andthus that the wound will be bigger. This is thus avoided when usingadaptors as seen in FIG. 14 b.

As stated above, the size and shape of the positioning body 11 of theguide base 12 is determined in order to minimize the surgicalintervention while also maximizing the stability of the guide base 12 inthe joint. While designing the guide base 12, e.g. by use of X-ray, MRor CT images from the patient it is normally desired to have apositioning body that is as large as possible, in order to ensuremaximum stability and proper positioning of the guide base 12 in thejoint. However, not all facts on the patient's joint may be knownthrough the X-ray, MR or CT images, and thus the surgeon may want toadjust the positioning body 11 during surgery. For example, osteophytesmight have formed in the joint and are often difficult to identify inthe imaging procedures. Also, the surgeon might find during surgery thatthe shape of the guide base 12 requires an unnecessarily large incisionto be able to insert the guide base 12 into the joint. In order tofacilitate adaptation of the size and shape of the guide base 12 duringsurgery, the positioning body may be arranged with breakage means 57that enable easy removal of part(s) of the positioning body 11 bytearing, fracturing or similar ways of breakage, see e.g. FIG. 5a . Suchbreakage means 57 may for example be provided through grooves, slots orperforations or other weakening of the structure.

The guide base 12 with guide body 13 aid with exact precision removal ofa volume of cartilage and subchondral bone and also guide the placementof the implant 10, the grafted plug 600 or the artificial plug in forexample a knee. Placement of the guide base 12 on the cartilage surfaceof a knee or a toe can be seen in FIGS. 5b and 5d . The use of the guidebase 12 and guide body 13 is further explained below in connection toFIGS. 14a -t.

The guide base 12 and the guide body 13 are manufactured using suitablematerials that are approved for use in medical procedures, e.g. aceramic, plastic, metal, metal alloy or alumina material, or acombination. The guide base 12, especially the cartilage contact surface50, is also preferably made of a material that is smooth, even and/orhas low friction, in order to lessen the risk of wear and damage to thecartilage on which it is to be placed. Such materials include e.g.metals ceramics and polymers such as acrylonitrile butadiene styrene(ABS). The used materials may further be polished. In a preferredembodiment the guide base 12 is made of a plastic material, such aspolyamide or epoxy, while the guide body 13 is made of a metal materialor stainless steel. The plastic material of the guide base 12 is easy tomanufacture, e.g. using selective laser sintering (SLS) orstereolithography (SLA) technologies, also when adapted for a specificpatient. It is also gentle to the cartilage surface of the joint. Themetallic material of the guide body 13 on the other hand, provides awear resistant material that is to be in contact with the insert tools,thus minimizing the risk of generating wear debris from the guide bodyfor example during drilling. It is also autoclavable and thus reusable.In one embodiment the guide base 12 is adapted to a specific patient, byhaving a cartilage contact surface 50 and a positioning body 11 that aredesigned to match the cartilage surface and the shape of the joint ofthe patient. In one embodiment the guide body 13 is made in a number ofstandard shapes and sizes, matching corresponding shapes and sizes of aset of standard implants 10, while in another embodiment the guide body13, as well as the implant 10, is also adapted to the specific patient.

Drill Adjustment Device

In a preferred embodiment the surgical kit further comprises a drilladjustment device 16 as for example illustrated in FIGS. 2, 6 and 7. Thedrill adjustment device 16 of the embodiment shown is arranged forattachment to the top of the guide body 13, e.g. by threads. The drilladjustment device 16 is further arranged such that it may be used toadjust the length of the guide channel 54. The length 31 of the guidechannel 54 determines the depth of drilling and cutting of the bone inthe joint, as will be described further below. Thus, by being able toadjust the length 31 of the guide channel the surgeon is also able toadjust the depth of drilling and cutting into the bone. The length 31 ofthe guide channel may be varied since the guide body 13 and the drilladjustment device 16 are able to move in relation to one another whenattached. This may for example be achieved by corresponding threading ofthe guide body 13 and drill adjustment device. Further, the guide body13 and/or drill adjustment device may be arranged such that the length31 of the guide channel may be varied at certain intervals, e.g. at 200μm intervals, or any other desired interval. This may for instance beachieved by arranging the guide body 13 and/or the drill adjustmentdevice 16 such that they are able to move in relation to one another atcertain intervals. For example, the threading may be arranged such thatthe guide body 13 and drill adjustment device 16 may be turned inrelation to one another at preset intervals, and that they are locked inrelation to each other or prone to hook each other at those intervals.This is readily implemented by a snap fit function.

The drill adjustment device 16 may be used by the surgeon to adjust thedepth of drilling, e.g. by increasing the drill depth in steps at thepreset intervals. The drill adjustment device is advantageously usedtogether with an implant dummy 36, as described below, to make sure thatthe drill depth in the bone matches the height 14 of the implant body27. This ensures that the articulate surface 15 of the implant 10 willbe in line with the surrounding cartilage at the site of implantationonce implanted. For further description of how the drill adjustmentdevice 16 is used during surgery, see below in connection with FIGS. 14j-p.

An alternative embodiment of a drill depth adjustment tool is disclosedin PCT application PCT/EP2011/058473, see e.g. pages 20-21 of thedescription and FIGS. 12-14. Another way to adjust the drill depth isalso to have an adjustable depth gauge on the drilling tool, see below.

Cartilage Cutting Tool

The cartilage cutting tool 3 is a tool which is used to cut thecartilage in the joint around the area of damaged cartilage to preparefor the insertion of the implant. The cartilage cutting tool may forexample be a cartilage cutter 3, as shown in FIGS. 2 and 9, a punch or acartilage cut drill. It is used inside the guide channel 54 of the guidebody 13 and fits in the guide channel 54, with a slight tolerance toallow a sliding movement of the cartilage cutting tool 3 in the guidechannel 54 (see FIG. 13a -1). The cartilage cutting tool 3 preferablycuts the cartilage so that the cut edges of the cartilage are sharp andsmooth. These sharp and smooth edges are of great importance when theimplant is placed into the prepared recess in the cartilage and bone. Ahole in the cartilage which is cut (or punched or drilled) with thecartilage cutting tool 3 according to the disclosure ends up with aprecise fit of the implant into the prepared cartilage since thecartilage cutting tool allows for an exact, precise cut. The recess inthe cartilage, made by the cartilage cutting tool 3 always correspondsto the chosen cross-section 81 of the implant body 27 in size and shape.

In one exemplifying embodiment, the cartilage cutting tool is acartilage cutter 3. The cartilage cutter 3 is used to cut the cartilagein the joint around the area of damaged cartilage to prepare for theinsertion of the implant with a cutting technique.

The cartilage cutter 3 has a handle 3 a, a cartilage cutter body 3 b anda cutting blade with sharp cutting edges 3 c. The cartilage cutter body3 b has a cross-sectional profile that is designed to correspond to theinner cross-sectional profile of the guide channel 54 with a toleranceenabling the cartilage cutter body 3 b to slide within the guide channel54 (see FIG. 13a -1). Also, the cross-sectional profile is designed tocorrespond to the cross-section of the implant. Thus, the cartilagecutter body 3 b fits the inside of the guide channel 54, see FIG. 13,with a slight tolerance to allow a sliding movement of the cartilagecutter in the guide channel 54. The fit ensures the correct, desiredplacement of the cartilage cutting edges 3 c on the cartilage surfaceand thus the precise removal of the damaged cartilage area.

The cartilage cutter 3 of the embodiment shown in FIG. 9 has a cartilagecutter body 3 b comprising a circular cutting blade that has been cut atan angle that is not perpendicular to the length of the cutter body 3 b.This creates an oval cutting edge 3 c with a pointy appearance, furtherincreasing the sharpness of the cartilage cutter 3. The cutting edge 3 cis arranged to cut the cartilage in a shape corresponding to thecross-sectional profile 81 of the implant body 27.

The material of the cartilage cutter body 3 b is chosen from materialswhich can give the cartilage cutter 3 sharp cutting edges 3 c. Thematerial also needs to be stable in order to withstand the pressure whenthe cartilage cutter 3 is pushed into the cartilage. Examples of suchmaterials are metals such as stainless steel or ceramic material or aplastic material or a hard coated material, preferably stainless steel.

The cutter body 3 b may be permanently attached to the handle 3 a, ormay, more preferably, be removably attached to the handle 3 a, such thatthe handle 3 a is reusable while the cutter body 3 b is be exchangeable(see FIG. 9).

The cartilage cutter 3 may be provided with a safety stop 4. The safetystop 4 has a cross-sectional profile that is larger than the grosssectional profile of the guide channel 54. In case the cutter would riskdigging too deep into the bone the safety stop 4 will be stopped againstthe top of the guide body 13 and/or drill adjustment device 16, thuspreventing the cartilage cutter 3 to be pushed deeper into the bone.This could happen e.g. when the patient suffers from osteoporosis. Thedistance between the tip of the cutting edge 3 c and the safety stop 4,and the relation between that distance and the length 31 of the guidechannel 54, will determine the depth that the cartilage cutter 3 isallowed to go into the cartilage and/or bone. The safety stop 4 may bearranged such that that distance is adjustable.

In alternative exemplifying embodiments, the surgical kit may comprise acartilage cutting tool in form of a punch, to punch out the cartilage,or in form of a cartilage cut drill, to cut the cartilage and alsocut/carve/drill the underlying bone, as are disclosed in PCT applicationPCT/EP2011/058473, see pages 17-18 and FIGS. 2, 5a-b and 10. The punchmay for instance be advantageous when the implant 10 has a non-circularshape and/or the extending post 23 is not centrally placed in relationto the implant body 27.

Drill and Bone Remover

In one embodiment, the surgical kit comprises a drill and bone remover 2(see FIGS. 2 and 10) that is used to drill a hole in the bone at thesite of cartilage damage, for fastening of the extending post 23 of theimplant 10 in the bone tissue, and simultaneously create a recess in thebone tissue at the site where the implant body 27 is to be received. Thedrill and bone remover 2 comprises a drill and bone remover body 20, acentral drill 22 and a bone remover 26, as shown in FIG. 10. The centraldrill 22 extends from the center of the drill and bone remover body 20,i.e. corresponding to the position of a centrally placed extending post23 on an implant 10 having a circular implant body 27. The diameter ofthe central drill 22 is the same as, or slightly smaller than, thediameter of the extending post 23 of the implant 10 that is to beimplanted. The bone remover 26 has a cutting edge that is placedperipherally around the central drill 22. The diameter of the boneremover 26 is the same as, or slightly smaller than, the diameter of theimplant body 27 of the implant 10 that is to be implanted, thus creatinga recess that matches the implant body, in which the implant body can bereceived. The cutting edge of the bone remover 26 is hard enough forcutting or carving bone. It may be made of materials such as stainlesssteel.

The drill and bone remover body 20 is designed to fit the inside of theguide channel 54 of the guide body 13, with a slight tolerance to allowa sliding movement of the drill and bone remover 2 in the guide channel54. In other words, the cross-sectional profile of the drill and boneremover body 20 matches the cross-sectional profile of the guide channel54 as well as the of the implant 10, see FIGS. 13a -1. The fit ensuresthe correct, desired placement of the drill and bone remover 2 on thecartilage surface and thus ensures the precise direction and placementof the drill hole for the extending post 23, as well as the recess forthe implant body 27, in the bone.

The drill and bone remover 2 is also equipped with a depth gauge 7. Thedepth gauge 7 of the drill and bone remover determines the depth of thecreated drill hole as well as the recess for the implant body 27. Thedepth gauge 7 has a cross-sectional profile that is larger than thecross sectional profile of the guide channel 54. The depth gauge 7 will,during the surgical procedure, rest against the top of the guide body 13and/or drill adjustment device 16, thus preventing the drill and boneremover 2 to drill/carve/cut deeper into the bone. The distance betweenthe tip of the cutting edge of the cutter 2 and the depth gauge 7, andthe relation between that distance and the length 31 of the guidechannel 54, will determine the depth that the is allowed to go into thecartilage and/or bone. The depth gauge 7 may be arranged such that thatdistance is adjustable. In a more preferred embodiment the distance isfixed and instead the drill/cut/carve depth is adjusted by adjusting thelength 31 through the drill adjustment device 16.

See FIG. 14g-p for a demonstration of how the drill and bone remover 2is used and how the drill depth is adjusted using the drill adjustmentdevice 16.

In alternative exemplifying embodiments, the surgical kit may, insteadof an integrated drill and bone remover, comprise a drill bit fordrilling the hole for the extending post and a reamer for removing bonewhere the implant body is to be received in the bone. Such embodimentsmay also comprise a drill guide and/or a reamer guide. Examples havebeen disclosed in PCT application PCT/EP2011/058473, see pages 18-20 and21 of the description and FIGS. 6-7. Such tools may for instance be usedwhen the implant 10 has a non-circular shape and/or the extending post23 is not centrally placed in relation to the implant body 27.

Implant Dummy and Dummy Reference

The implant dummy 36 and dummy reference 37, see FIGS. 2 and 11 a-b, areused to make sure that the cut, carved or drilled recess in the bonethat is to receive the implant body 27, is deep enough to fit theimplant. This is very important, since the articulate surface 15 of theimplant 10 must not project over the surface of the surroundingcartilage tissue. If it would it could cause a lot of damage to thesurrounding cartilage and to the cartilage on the opposite side of thejoint. Preferably the articulate surface 15 should form a continuoussurface with the surrounding cartilage, neither projecting above norbeing sunken below the surface of the surrounding cartilage. Thechecking of the recess depth is difficult or impossible to do with theimplant 10 itself, since the implant 10, e.g. with its extending post23, is designed to be fixed in the bone once inserted, and thus isdifficult or impossible to remove. The implant dummy, on the other hand,is designed for easy removal from the recess once the recess depth hasbeen checked.

The implant dummy 36, see FIG. 11b , has an implant element 41 that isdesigned to match the implant body 27. The lower surface 41 a of theimplant element 41 is a replica of the bone contact surface 21 of theimplant that is to be implanted. That is, if the implant 10 and bonecontact surface 21 is custom made for the specific patient, the implantelement 41 and its lower surface 41 a will also be custom made and thelower surface 41 a be a replica of the bone contact surface 21. Thecross-sectional profile of the implant element 41 corresponds to thecross-sectional surface 82 of the implant body, or is slightly smallerin order to ensure easy removal of the implant dummy from the recess.

The implant dummy 36 also has a top surface 43. The distance 46 betweenthe lower surface 41 a of the implant element 41 and the top surface 43corresponds to the distance that you get when adding the thickness 14 ofthe implant body 27 (corresponding to the depth of the recess in thebone plus the thickness of the corresponding cartilage), the height ofthe guide hole 53 and/or the length 51 a of the dummy reference 37,taking regard to any overlap between the guide hole 53 and the dummyreference 37 when they are attached. For a demonstration on how therecess depth is checked using the implant dummy 36 together with thedummy reference 37, see below in connection with FIGS. 14j-p . In oneembodiment the thickness 41 b of the implant element 41 is the same asthe thickness 14 of the implant body 10, such that the recess depth canalso be checked directly using the implant element 41 only, i.e. withoutthe dummy reference 37 and top surface 43.

The dummy reference 37, see FIG. 11a , is arranged to fit to, andpossibly releasably attach to, the guide hole 53 of the guide base 12,see FIGS. 14j-k . It is also arranged to receive the implant dummy 36,by being provided with a channel 58. The cross-sectional profile ofchannel 58 corresponds to the cross-sectional profile of the guidechannel 54. Thus the channel 58 is able to receive the implant dummy 36,and also the implant 10, with a slight tolerance that allows a slidingmovement of the implant dummy 36 in the channel 58, see FIGS. 13a -1,bottom row to the right. The dummy reference 37 and channel 58 has alength 51 a.

To ensure that the implant dummy 36 is placed in a correct orientationin the recess of the bone, i.e. in an orientation that corresponds tothe orientation that the implant 10 is to be inserted in, the topsurface 43 and/or the implant element 41 may be provided with some kindof marking or shape fit element 43 a. A corresponding marking or shapefit element 51 b is then provided also on the dummy reference and/or theguide base 12.

Mandrel

The mandrel 35 (see FIGS. 2 and 12) consists of a solid body and has amandrel surface 35 a that is designed to fit the articulate surface 15of the implant 10, i.e. it has a corresponding cross-sectional profileand preferably also a corresponding, although inverted, curvature. Themandrel may also be designed to fit the inside of the guide channel 54,with a slight tolerance to allow a sliding movement of the hammer tool35 in the guide channel 54. The mandrel 35 is preferably used inside theguide channel 54 to hammer the implant in place, for support and to getthe proper angle, or may alternatively be used without the support fromthe guide channel 54, see FIGS. 14r-s . The height 68 of the mandrel 35is in one embodiment the same height 31 as of the guide channel 54. Forsuch embodiment, once the mandrel 35 is hammered in the same level asthe top of the guide channel, the hammering and thus the placement ofthe implant is finished.

The hammer tool 35 may also be accompanied by a hammer tool adapter 34,see FIG. 12, for facilitating the use of the hammer tool and minimizingthe absorption of the shock caused by the hammer tool and/or minimizethe risk of scratching the surface of the implant 10 while hammering. Itis made from a soft material that is gentle to the implant surface, e.g.a rubber or plastic material.

Detailed Description of a Method for Implanting the Implant Using theSet of Tools

Use of the surgical kit and set of tools disclosed herein will now befurther explained in connection with an exemplifying embodiment shown inFIGS. 14a-t . The example concerns a surgical kit for implantation of asmall implant 10 into a knee joint. The same principles do however applyalso for other joints as well as for mosaicplasty surgery. For thelatter an implant body 13 with more than one guide channel 54 may beused, and the grafted plug 600 may be a selection of bone and cartilageplugs from a healthy part of the joint, or a selection of artificialimplant plugs of various sizes.

1. Localize the area of the injury and determine the desired size andshape of the implant, see FIG. 1. The position and size of the cartilagedamage can be identified by a combination of MRI or CT images or bydGEMRIC technique. The images may then be handled in special surgicalplanning tool software. All of the parts in the surgical kit may beindividual adjusted depending on size of cartilage damage, location ofthe cartilage damage and also depending on a simulation of theindividual surface appearance without damage. Alternatively an implantfrom a set of predetermined implants may be selected and the set oftools designed or selected thereafter.

2. The implant 10 and set of tools are manufactured depending on; thesize of the implant needed, the localization of the injury, theappearance of the cartilage surface intended to be replaced. The designsmay be based on the MR images/CT-scanning images from the joint of theperson having the cartilage damage, using the surgical planningsoftware. The surgical planning software is connected to manufacturingdevices, for example a laser printer, a lathe and/or a reamer, and theparts of the kit are manufactured using e.g. additive manufacturing,laser sintering techniques, turnery or reaming.

3. A surgical opening is made in the leg tissue depending on thelocalization of the injury and the size of the implant and alsodepending on the size and conformation of the guide tool.

4. The guide base 12 is placed on the surface of the knee cartilage, seeFIG. 14a . The guide base 12 fits due to the fact that it is custom madeto be placed in that particular position. This allows the surgicalprocedure (cartilage and bone removal and insertion of the implant) tobe performed with good accuracy and precision. If necessary the guidetool can be further stabilized with rivets or pins on a part of theguide tool that is in contact with parts of the joint that have nocartilage tissue. The rivets or pins may also be attached by additionaluse of adapters 17 that are first attached to the guide base 12 viaattachment means 9, see FIG. 14 b.

5. The guide body 13 is attached to the guide base 12 via the releasableattachment means 47, see FIGS. 14c-d . The guide body 13 may further beprovided with a drill adjustment device 16 and/or a drill insert 8 thatprovides a guide channel 54 of the right shape and size, i.e having across-sectional profile that corresponds to the cross-sectional profile81 of the implant that is to be implanted.

6. When the guide body 13 has been attached to the guide base 12, thecartilage cutting tool, here a cartilage cutter 3, is used to cut out apiece of the cartilage that corresponds to the cross-section 81 of theimplant 10 that is to be implanted (see FIGS. 14e-f ). The cartilagecutter body 3 b fits exactly in the guide channel 54 and thus by turningcan make a hole in the cartilage of the desired size and with precisionto fit the implant size and at the desired position. A depth gauge 4 onthe cartilage cutter 3 can be used in order to help make sure that thecutting is not made too deep.

7. After the piece of cartilage has been removed, the drill and boneremover 2 is then inserted in the guide channel 54, see FIGS. 14g-h .When the drill and bone remover 2 is turned/drilled the central drill 22will give an exact, desired placement of a bore in the bone where theextending post 23 of the implant 10 is to be inserted. The bore ispreferably made with a central drill 22 having a slightly smallerdiameter than the diameter 18 of the extending post 23 of the implant 10so that when the implant 10 is hammered in place it will be firmlyattached in the bone. When the drill and bone remover 2 isturned/drilled the cutting edge of the bone remover 26 will at the sametime create a recess in the bone at the exact desired place and of thedesired shape to fit the implant body 27 of the implant 10. Such recesswill have a cross-sectional profile that is the same as thecross-sectional profile of the drill and bone remover 2, i.e. the sameas the cross-sectional profile of the implant 10.

8. After the drilling and cutting the drill and bone remover 2, as wellas the guide body 12 are removed, see FIG. 14i . The site ofimplantation can now readily be cleaned from wear and waste from thedrilling and cutting, and inspected to see whether the desired resulthas been achieved.

9. Now, the implant dummy 36 and dummy reference 37 are used to checkwhether the recess in the bone is deep enough to receive the implant 10,without the implant 10 projecting over the surface of the surroundingcartilage. The dummy reference 37 is first placed and possibly attachedto the guide hole 53 of the guide base 12, see FIGS. 14j-k . The implantdummy 36 is then inserted to the channel 58 of the dummy reference 37,such that the implant element 41 is in an orientation corresponding tothe orientation in which the implant 10 is to be implanted. This can beensured e.g. by a marking or shape fit element 43 a on the implant dummyand a corresponding marking or shape fit element 51 b on the dummyreference and/or the guide base 12.

The implant dummy 36 and dummy reference 37 are arranged such that whenthe depth of the recess in the bone that is to receive the implant body27 is deep enough the top surface 43 of the implant dummy 36 and the topedge of the dummy reference should lie flush or in line with each other,see arrow in FIGS. 14l and 14p . This is achieved by arranging theimplant dummy 36 and the dummy reference 37 such that the distance 46between the lower surface 41 a of the implant element 41 and the topsurface 43 corresponds to the distance that you get when adding thethickness 14 of the implant body 27 (corresponding to the depth of therecess in the bone plus the thickness of the corresponding cartilage),the height of the guide hole 53 and/or the length 51 a of the dummyreference 37, taking regard to any overlap between the guide hole 53 andthe dummy reference 37 when they are attached (see also above).

As is seen by the arrow in FIG. 14l the top surface 43 of the implantdummy 36 and the top edge of the implant reference do not lie flush,i.e. not in line, with each other. Thus, some more drilling/cutting intothe bone should be made. The implant dummy 36 and dummy reference 37 areremoved from the guide base 12 and the guide body 13 with drilladjustment device 16 attached again to the guide hole 53, see FIG. 14m .The drill adjustment device 16 is then adjusted such that the length 31of the guide channel 54 is shortened. This may for instance be done byturning the drill adjustment device 16 at a number of preset intervals,e.g. one, two or three times 200 μm, or any other number times any otherpreset interval, see also above, and FIG. 14 n.

The drilling and cutting procedure is then repeated; see points 7-8 andFIG. 14o , and the implant dummy 36 and dummy reference 37 used to checkthe drill depth again, see FIG. 14p . In FIG. 14p the top surface 43 andthe top edge of the dummy reference lie flush with each other, seearrow. The recess in the bone then is of suitable depth and is ready toreceive the implant 10.

10. The implant 10 may be guided to the exact matching recess at thesite of implantation through the guide channel 54 of the guide body 13,or alternatively be placed at the site of implantation without theguide. The later alternative is shown in FIG. 14q for illustrativepurposes.

11. The mandrel 35 is then used, also either with or without supportfrom the guide channel 54 of the guide body 13, to hammer the implant inposition and firmly attach it to the bone. The mandrel 35 is placed ontop of the implant 10 and then a hammer or similar tool is used tohammer or push the mandrel 35 (as shown symbolically by the arrow) suchthat the implant is forced in place, see FIG. 14 s.

12. Lastly, the hammer tool 35 and the guide base 12 are removed, theimplant 10 is implanted at the site of cartilage damage, see FIG. 14t ,and the incision wound can be stitched.

FURTHER EMBODIMENTS

Embodiments comprise a modular surgical kit for repair of diseasedcartilage at an articulating surface of a joint, for use with a medicalimplant (10), a grafted plug (600) or an artificial plug having animplant body (27, 627) with a predetermined cross-sectional profile(81), the modular surgical kit comprising; a guide base (12) having apositioning body (11) with a guide hole (53) through said positioningbody (11), wherein:

the positioning body (11) has a cartilage contact surface (50) that isdesigned to fit the contour of cartilage or subchondral bone in thejoint in a predetermined area surrounding the site of diseasedcartilage;

the guide hole (53) has a muzzle (29) on the cartilage contact surface(50) at a position corresponding to the site of the diseased cartilage;and

a guide body (13) with a guide channel (54), the guide channel (54)having a cross-sectional profile that is designed to correspond to thecross-sectional profile (81) of the implant body (27, 627) and having amuzzle 32;

wherein

the positioning body (11) comprises means for releasably connecting (47)to the guide body (13) such that, when connected, the guide channel (54)is positioned in relation to the positioning body (11) such that itsmuzzle (32) emanates at a site corresponding to the site of implantationinto the bone.

Variants of these embodiments comprises one or more of the features:

wherein the cartilage contact surface (50) is custom designed to fit thecontour of the cartilage or subchondral bone of a specific patient;

wherein the cartilage contact surface (50) is designed to fit thecontour of the cartilage or subchondral bone of an average patient;

wherein the guide body (13) comprises at least two guide channels (54),each guide channel (54) having a cross-sectional profile that isdesigned to correspond to the respective cross-sectional profile (81) ofat least two implant bodies (27, 627);

wherein the guide channel (54) is provided by a guide insert (8) that isdesigned to fit in the guide body (13);

further comprising a drill adjustment device (16) being arranged toenable adjustment of the drill depth e.g. in certain length intervals;

wherein the positioning body (11) is arranged with at least one breakagemeans (57) for enabling easy removal of part of the positioning body(11) by tearing, fracturing or similar breakage, such means (57) forexample being provided by grooves, slots or perforations or otherweakening of the structure;

wherein the positioning body (11) is arranged with at least oneattachment means (9) for enabling easy attachment of adaptors, pins andother devices used during surgery, e.g. by snap fit, this embodiment mayfurther comprise adaptors (17) fitting the attachment means (9), forenabling flexible attachment of pins and other devices;

further comprising an insert tool with a cross-sectional profile that isdesigned to correspond to the cross-sectional profile of the guidechannel (54) with a tolerance enabling the insert tool to slide withinthe guide channel (54);

wherein the insert tool is a cartilage cutting tool 3 with across-sectional profile that is designed to correspond to thecross-sectional profile of the guide channel (54) with a toleranceenabling the cartilage cutting tool 3 to slide within the guide channel(54), and comprising a cutting blade with sharp cutting edges 3 c ableto cut the cartilage in a shape that substantially corresponds to thecross-section (81) of the implant body (27);

wherein the insert tool is a drill and bone remover (2) with a drill andbone remover body 20 having a cross-sectional profile that is designedto correspond to the cross-sectional profile of the guide channel (54)with a tolerance enabling the drill and bone remover (2) to slide withinthe guide channel (54), the drill and bone remover (2) furthercomprising a central drill (22), for drilling a bore to receive theextending post (23) of the implant (10), and a bone remover (26) forcutting a recess in the bone to receive the implant body (27) of theimplant (10);

wherein the insert tool is a mandrel (35) with a mandrel surface (35 a)that is designed to fit the articulate surface (15) of the implant (10)and having a cross-sectional profile that is designed to correspond tothe cross-sectional profile of the guide channel (54) with a toleranceenabling the mandrel (35) to slide within the guide channel (54);

further comprising an implant dummy 36 with an implant element 41 thatis designed to match the implant body 27 and having a lower surface 41 athat is a replica of the bone contact surface 21, but comprising noextending post 23;

further comprising a dummy reference 37 that is arranged to fit to, andpossibly releasably attach to, the guide hole 53 of the guide base 12and is arranged to receive the implant dummy 36, by being provided witha channel 58.

Further Embodiments of Drill Bit

Embodiments describe an implant specific drill bit 202, see FIGS. 15-18b, which is a combination of a drill and bone remover that is used todrill a recess, a hole or bone cavity in the bone at the site ofcartilage damage, for example in a joint in a patient. The recess madeis in the same size and shape as the implant, or slightly smaller thanthe implant, and is intended to be used for fastening and/or implantingan implant with a press fit. A suitable implant 210 to be implantedaccording to the disclosure, see FIGS. 16b, 18b , comprises an extendingpost 223 and an implant body 227 and is to inserted in the recess formedusing the implant specific drill bit 202 according to the disclosure, inthe bone tissue 232 and cartilage tissue 234 in the joint, see FIG. 17.

The implant specific drill bit 202 according to the disclosure comprisesa drill and bone remover body 220, a central drill part 222 and a boneremover part 226, as shown in FIG. 15. The central drill part 222extends from the center of the drill and the bone remover body 220 has aproximal end and a distal end and a longitudinal y-axis extendingbetween the proximal end and the distal end, i.e. corresponding to theposition of a centrally placed extending post 223 on an implant 210having a circular implant body 227 when the drill bit is used fordrilling a recess.

The implant specific drill bit 202 may for example have the followingmeasures: a drill and bone remover body 220 may be 3-40 mm or 5-40 mm indiameter approximately corresponding to the diameter of the specificimplant body 227, or for example 1-5% smaller diameter than the specificimplant. The drill and bone remover body 220 may have a length 322 of2-500 mm or 4 mm-3 cm or 4 mm-5 cm or a length which the drill bitsufficient support when used together with a guide tool in a guidechannel. The bone remover part 226 may have similar diameter than thebone remover body 220 or slightly less.

The central drill part 222 may be cylindrical or conical in shape and be0.7-10 mm in diameter (if conical shape, the diameter refers to thebroadest part) and have a length 272 of 2-300 mm mm or may have adiameter 252 20% less than the diameter of the drill and bone removerbody 220 or the bone remover part, see for example FIG. 17.

The bone remover part 226 comprises a shape cutting edge 228 and theshape cutting edge may further comprise protruding flanges 320 whichprotrudes from cutting edge surface with a length 324 approximately0.3-3 mm and a width 326 of 0.3-1.5 mm or 0.3-2 mm, see for example FIG.17. The protruding flanges 320 is made of a material suitable forcutting bone, for example stainless steel and may have the same materialas the shape cutting edge 228.

In one alternative embodiment, as illustrated in FIG. 19b the angle 328between the shape cutting edge 228 and the longitudinal y-axis 270 ofthe implant specific drill bit 202 is 90° or less.

If the implant to be implanted has a curved articulating surface 229 theangle 328 between the shape cutting edge 228 and the longitudinal y-axis270 of the implant specific drill bit 202 is preferably 80° or less inorder to keep the volume of the implant body lower.

The implant specific drill bit further comprises a shaft 221 which mayhave suitable measures and shapes to fit for using together with adrilling machine.

The drill bit according to the disclosure is implant specific. Thediameter of the central drill part 222 is the same as, or slightlysmaller than, the diameter of the extending post 223 of the implant 210that is selected to be implanted in the joint. The bone remover 226 ofthe bone remover body 220 has a shape cutting edge 228 that is placedperipherally around the central drill part 222. The diameter of the boneremover 226 is the same as, or slightly smaller than, the diameter ofthe implant body 227 of the implant 210 that is to be implanted, thuscreating a recess that matches the implant body, in which the implantbody can be received. See FIGS. 16a and 16b and FIGS. 18a and 18b forschematic illustrations of an implant and an implant specific drill bit202 according to the disclosure. The shape cutting edge or blade 228 ofthe bone remover 226 and the central drill part 222 is hard enough forcutting or carving bone.

The implant specific drill bit 202 according to the disclosure may bemade of materials such as stainless steel. The shape cutting edge orblade 228 of the implant specific drill bit or implant specific drillbit 202 according to the disclosure is designed in the same shape as animplant body which is selected to be implanted in the bone cavity madeusing the implant specific drill bit.

The shape cutting edge or blade 228 of the implant specific drill bit202 may be flat (see FIG. 18a ) if the implant to be inserted comprisesa flat bone contacting surface 238 or shape cutting edge or blade 228may protrude from the bone remover forming flanges 320, see FIG. 16a ifthe implant body 227 of the implant to be inserted comprises a shapecutting edge or blade 228 formed as a protruding anchoring ring portion236 or rim 236, see FIG. 16b . The implant specific drill bit 202according to the disclosure is designed after the shape of the implantto be inserted.

The drill and bone remover body 220 is constructed for forming a bonecavity for an implant directly in a joint and may alternatively bedesigned to fit the inside of a guide instrument for example inside aguide channel of a guide body of a guide instrument, with a slighttolerance to allow a sliding movement of the implant specific drill bit202 in such a guide channel. The implant specific drill bit 202 may alsobe equipped with a depth gauge 207 and may be used together with a guidetool. The depth gauge 207 of the implant specific drill bit determinesthe depth of the created drill hole as well as the depth of the recessfor the implant body 227.

The cross-sectional profile of the drill and bone remover body 220, thebone remover part 226, the shape cutting edge 228 and the central drillpart 222 matches or is slightly smaller, for example 0.1-5 volume %smaller than the cross-sectional profile of an implant 210 and itsextending post 223, its implant body 227 and also matches the shape ofthe implant body which further may comprise an anchoring ring portion236. The fit ensures the correct, desired placement of the implantspecific drill bit 202 on the cartilage surface and thus ensures theprecise direction and placement of the drill hole for the extending post223, as well as the recess for the implant body 227, in the bone.

The depth of the drilling may be adjusted manually if an implantspecific drill bit 202 is used that does not comprise a depth gauge 207and if the drill bit is used without guidance of a guide tool.

A Design Method Designing the Implant Specific Drill Bit 202

A design method according to embodiments comprises the following steps;

determining or selecting a size and shape of an orthopedic implant 210comprising a circular shaped implant body 227 and a centrally placedcircular shaped extending post 223 protruding from the bone contactingsurface 238 in a longitudinal y-axis 260 direction of the implant 210;and

a. designing the size and shape of said implant specific drill bit 202comprising a bone remover part 226, a central drill part 222 and a shapecutting edge 228 located one surface of the bone remover part 226, andwherein the central drill part 222 protrudes from the shape cutting edge228 surface in a longitudinal y-axis 270 direction of the implantspecific drill bit 202 depending on the selected size and shape for saidimplant 210 in determined or selected step a, wherein;

the width 240 of the broadest part of the bone remover 226 in a sideview corresponds to, or is slightly smaller than, the diameter 250 ofthe implant body 227 of the implant 210 that is to be implanted;

the rotational volume and the length 272 of the central drill part 222corresponds to, or is slightly smaller than, the diameter 252 of theextending post 223 of the implant 210 that is to be implanted;

the curvature of the shape cutting edge 228 that is placed anywhereperipherally around or surrounding the central drill part 222 of theimplant specific drill bit 202 corresponds to the curvature of the bonecontacting surface 238 of the implant.

The rotational volume 239 is a fictive volume, which is illustrated inFIG. 20a , and which is achieved by rotating the implant specific drillbit 202 around its longitudinal axis 270. In embodiments theconstruction of the drill bit is not symmetrical in shape as theconstruction of the specific implant. The rotational volume of theimplant specific drill bit is symmetrical and is designed to correspondto the volume of the specific implant. This rotational volume (239) alsocorresponds to the volume that is removed when the implant specificdrill bit 202 according to the disclosure is used for drilling a cavity230 in the bone and or the cartilage in the joint. The rotational volumeis therefore a copy of the volume and size and shape of the implant(comprising an implant body and the extending post etc., even though theimplant specific drill bit 202, when not rotated, may have another shapethan the implant. See also FIG. 17.

The implant may be selected from a kit of implants of different shapesand sizes or may be designed to fit a specific cartilage damage in aspecific patient. Individually constructed implants are made byinvestigation of the joint using for example MR and then using that datato create an implant body which will be sufficient to repair thecartilage damage in that specific patient.

FIG. 20a shows an exemplified embodiment of an implant specific drillbit comprising a shape cutting edge on only one side of the longitudinaly-axis of the drill bit and having the rotational volume correspondingto the specific implant.

A design method according to the disclosure for designing the implantspecific drill bit 202 may comprise a step wherein the shape cuttingedge 228 of the drill bit 202 is designed to correspond to the shape andcurvature of an implant with a bone contacting surface 238 which is flator a an implant 210 with a bone contacting surface 238 which comprisesan protruding anchoring ring portion 236.

An implant with a protruding anchoring ring portion 236 is very wellanchored in the bone cavity since both the extending post and theprotruding anchoring ring portion 236 of the implant is contributing infastening of the implant placed in a joint.

The shape and size of the implant are calculated or selected dependenton the size and shape of the cartilage damage, and dependent on thecurvature of the contour of the cartilage and/or of the subchondral bonein the area substantially coinciding with the cartilage damage.

The following steps may be comprised in generating design parameters foran implant specific drill bit according to the disclosure:

Generating a cross-section for the bone remover part 226 of the implantspecific drill bit 202 dependent on and substantially corresponding tosaid determined cross-section of the implant body 227 of an implant 210.The cross-section for the implant body is generated or selected from akit of implants to correspond to the cross-section shape determined forthe cartilage damage.

Generating a length and a cross-section profile for a specific drill bit222 wherein the specific drill bit 222 is extending from a shape cuttingblade or edge 228 of the implant specific drill bit 202 and is dependenton or corresponding to, the length and cross-section profile for anextending post 223 of an implant. The size and shape of the extendingpost is selected automatically according to a predetermined scheme or isselected manually by an operator.

Generating the shape of a shape cutting blade or edge 228 of an implantspecific drill bit 202 may be flat or comprise protruding flanges 320depending on, or corresponding to the size and shape and curvature ofthe bone contacting surface 238 of an implant 210.

FIGS. 16a and 16b and also FIGS. 18a and 18b show examples of the sizeand shape of an implant specific drill bit 202 which is designeddependent of or corresponding to the design; the shape, size andcurvature of an implant 210.

The length of the implant specific drill bit 202 is depending on theneed for a long or short shaft for attaching the drill bit to a drill.

The length of the drill and bone remover body 220 is selected dependenton the intended use of the implant specific drill bit 202. The length ispreferably longer than the depth or height of the implant body of theimplant intended to be implanted. For example a use of the implantspecific drill bit 202 inside a guide tool guiding and supporting thedrill bit may lead to a design of a drill and bone remover body 220which corresponds to the length of a guide channel of such a guide tool,for maximum support of the drill bit during drilling.

Determination of the cartilage damage and alternative embodimentsgenerating design parameters of a medical implant 210 and therebygenerating design parameters for an implant specific drill bit.

An image or a plurality of images representing a three dimensional imageof a bone member of the joint in a patient's limb is obtained byselecting one of a per se known imaging technology for non-invasiveimaging of joints, such as magnetic resonance imaging (MRI),computerized tomography (CT) imaging or a combination of both, or othersuitable techniques such as delayed Gadolinium-enhanced MRI of cartilage(dGEMRIC) techniques. The image of the joint should comprise arepresentation of cartilage in the joint as well as the underlyingsubchondral bone in the area of the cartilage damage. Image data makingup a three dimensional image representation of the joint is stored in adigital format in a manner that enables to keep track of the dimensionsof the real joint that the image depicts.

The image data is analyzed in a data processing system to identify anddetermine physical parameters for the cartilage damage. The physicalparameters to determine comprise the presence, the location and the sizeand shape of the cartilage damage, as well as curvature of the surfacecontour of the cartilage or the subchondral bone in an area of thecartilage damage.

In one embodiment of the inventive concept the design system operates todetermine physical parameters on images of the patient's individualjoint and the current cartilage damage, and thereby produces anindividually designed implants which shape and size is used as model fordesigning shape and size of the implant specific drill bit 202 accordingto the disclosure.

Further in one exemplified embodiment, the contour curvature for anarticulate surface of a substantially plate shaped implant body 227dependent on said determined surface curvature of the cartilage and/orthe subchondral bone.

The contour curvature for the articulate surface of the implant body isgenerated to correspond to the curvature that covers the cartilagedamage.

In another embodiment the design system operates on a collection ofimages of joints constituting a statistical basis for determiningphysical parameters for producing an implant 210 which then is used as amodel for designing an implant specific drill bit according to thedisclosure.

Embodiments comprises a design method designing an implant specificdrill bit 202 comprising:

determining or selecting a size and shape of an orthopedic implant 210comprising a circular shaped implant body 227 and a centrally placedcircular shaped extending post 223 protruding from the bone contactingsurface 238 in a longitudinal y-axis 260 direction of the implant 210;and

selecting design parameters for the implant specific drill bit 202 by:

selecting the width 240 of the broadest part of the bone remover 226 ina side view to correspond to, or to be slightly smaller than, thediameter 250 of the implant body 227 of the specific implant 210 that isto be implanted

selecting the rotational volume and the length 272 of the central drillpart 222 to correspond to, or to be slightly smaller than, the diameter252 of the extending post 223 of the specific implant 210 that is to beimplanted

selecting the curvature of the shape cutting edge 228 that is placedanywhere peripherally around or surrounding the central drill part 222of the implant specific drill bit 202 to correspond to the curvature ofthe bone contacting surface 238 of the implant.

In further embodiments the determining the size and shape of saidimplant may either be performed by:

selecting implants from a kit of implants of different predeterminedsizes; or

-   -   by individually designing the size and shape of an implant;        and wherein the size and shape of the selected implant is        corresponding in large or partly or substantially to the size        and shape of a cartilage damage in a specific patient.

Further embodiments may comprise:

wherein said shape cutting edge 228 in side view is designed tocorrespond to the shape of at least one side of the bone contactingsurface 238 in a cross-sectional view of the specific implant 210; andwherein the bone contacting surface 238 is substantially flat or a bonecontacting surface 238 which comprises an protruding anchoring ringportion 236.

wherein the volume of the part of the designed implant specific drillbit 202 which corresponds to fit the implant 210 is 0.1-5% smaller thanthe volume of the implant 210 to be implanted, allowing for press fit ofthe implant 210 placed in the recess made by the implant specific drillbit 202 according to the disclosure.

wherein the shape cutting edge comprises at least one flange 320.

wherein the flange has a length 224 of 0.3-3 mm protruding from theshape cutting edge 228 and/or a width 225 of 0.3-2.0 mm or 0.3-2.0 mmcorresponding to the length 235 in a cross-sectional view of theanchoring ring portion 236 of an implant 210.

wherein the angle 328 between the shape cutting edge 228 and thelongitudinal y-axis 270 of the implant specific drill bit 202 isdesigned to be 90° or less or for example 80° or less or 70° or lessbased on the selected specific implant and its corresponding angle.

wherein the length 272 of the central drill part 222 of the implantspecific drill bit is designed to be 2-300 mm corresponding to orslightly longer, or 1-5% longer than the length 282 of the extendingpost 223 of an specific implant 210.

Further embodiments comprises an implant specific drill bit 202 designedaccording to the design method in any of the above embodiments forproducing bone cavities for receiving orthopedic implants, said drillbit 202 comprises:

a drill and bone remover body 220 having a proximal end and a distal endand a longitudinal axis extending between the proximal end and thedistal end; and

a bone remover part 226 located in one end of the bone remover body 220;and

a central drill part 222 protruding from said bone remover part 226;

wherein said bone remover part 226 comprises a shape cutting edge 228which is placed peripherally around the central drill part 222. The boneremover part 226 may comprise a flat surface or a surface which furthercomprises flanges 320.

One embodiment comprises a kit comprising an implant specific drill bit202 designed according to any of the above method embodiments and animplant 210, wherein said an implant specific drill bit (202) isdesigned to correspond to the size and shape of said implant 210.

FIG. 21 shows an image of a recess drilled in a cartilage coated bonetissue with a conventional drill, the edges of the recess is uneven andthe cartilage is frayed. Further, with conventional technology the edgesof recess in the cartilage may be misaligned relative the edges of therecess of the bone tissue. The embodiments described herein improve thealignment of the recesses in the cartilage and the bone tissue, as shownin FIG. 22.

FIG. 23 shows an embodiment of the lower part of a drill bit 202 havingsharp pre-cutting edges 410, 414 and shark fin shape cutting edges 412,416. The pre-cutting edges 410, 414 protrude, for example in the rangeof 0.1 to 1 mm such as 0.5 mm, in relation to the shark fin shapecutting edges 412, 416 in order to cut through the cartilage beforecutting the recess in the bone tissue. Different embodiments compriseone or more cutting edges, for example three or four cutting edges. Inembodiments each shape cutting edge 228 is paired with an associatedsharp precutting edge 410, 414. FIG. 24a and FIG. 24b show images of anembodiment of such a drill bit. In FIG. 24a the sharp cutting edges 410and 414 are indicated, whereas FIG. 24b shows the drill bit turned 45degrees around its rotational axis and the shark fin shape cutting edges412 and 416 being visible. In embodiments, the sharp pre-cutting edges410, 414 of the drill are longer, for example 0.2 mm longer, than theshark fins (edges) of the implant's hat in order to provide a gap underthe implant. In embodiments, the thickness of the shark fin shapecutting edges 412, 416 are wider, for example 0.2 mm wider, than theshark fins (edges) of the implant's hat in order to allow fitting theimplant in the recess.

FIG. 25a and FIG. 25b shows how the shape of the lower part of the drill202 corresponds to the bone contacting part of the implant 210.

Embodiments of the kit comprises a drill guide having guides for one,two or more adjacently positioned bores. The kit and/or its parts enablethe creation of a recess with desired angle or tilting in relation tothe surface of the cartilage and/or bone. The kit and/or its partsenable removal of tissue to match the geometry of an implant.Embodiments of the drill enables the drilling of a two parallel bores tomake a recess for an implant with a hat and an extending post.Embodiments of the drill comprises a drill body with 220 with a diametersmaller, for example 0.2 mm smaller, than the diameter of the hat of anassociated implant in order to provide a press fit of the implant in therecess in the bone tissue. Embodiments of the drill comprises a drillpeg 222 having a smaller diameter, for example 0.4 mm smaller, andhaving a longer extension, for example 2 mm longer, than the peg or postof an associated implant in order to provide a press fit for the implantwith the bone tissue. Embodiments of the drill comprises a sharp tip inorder to avoid slipping on the cartilage surface. Embodiments of thedrill comprises one or more flutes enabling removal of tissue duringdrilling. In embodiments of the drill, all or some of the edges of thedrill stop and/or shaft shall be broken/chamfered/rounded. Inembodiments, the large drill diameter and/or the drill peg has a part ofits peripheral surface area offset inwards in order to minimize frictionduring drilling.

The invention claimed is:
 1. A drill tool for implant surgery comprisinga specific implant drill bit having a longitudinal y-axis, a proximalend, and a distal end opposite the proximal end in the longitudinaly-axis, the implant drill bit comprising: a first drill bit partadjacent the distal end and comprising one or more cutting edges locatedat a first peripheral distance from the longitudinal y-axis, wherein theone or more cutting edges of the first drill bit are arranged to drillan implant post recess for an implant post of a specific implant to beimplanted; and a second drill bit part further from the distal end thanthe first drill bit part and comprising: one or more shape cuttingedges, wherein at least one of the one or more shape cutting edgescomprises a protruding flange protruding from the one or more shapecutting edges along the longitudinal y-axis with a length of 0.3-3 mm,wherein the protruding flange creates a U-shaped space at the one ormore shape cutting edges; and one or more sharp pre-cutting edges formedalong the protruding flange and extending beyond said one or more shapecutting edges towards the distal end in the longitudinal y-axis, whereineach of the one or more shape cutting edges and the one or more sharppre-cutting edges are located at a second peripheral distance from thelongitudinal y-axis, the second peripheral distance being greater thanthe first peripheral distance such that the one or more shape cuttingedges and the one or more sharp pre-cutting edges are arranged to drillan implant body recess for an implant body of a specific implant to beimplanted, wherein the implant body recess has a depth corresponding tothe thickness of the implant body between an articulating surface of theimplant body and a bone contact surface of the implant body, the bonecontacting side being opposite to the articulating surface, and whereinthe implant body recess has a uniform cross-section perpendicular to they-axis throughout the depth of the implant body recess, and wherein theshortest distance across a cross-section perpendicular to the y-axis ofthe implant body recess is larger than the largest distance across across-section perpendicular to the y-axis of the implant post recess. 2.The drill tool according to claim 1, wherein at least one of the one ormore sharp pre-cutting edges is arranged to drill a recess separate fromthe implant post recess and that extends along the longitudinal y-axisbeyond the recess for the implant body, in order to provide a gap underthe implant body.
 3. The drill tool according to claim 1, wherein theprotruding flange has a width of 0.3-1.5 mm.
 4. A drill tool for implantsurgery comprising a specific implant drill bit having a longitudinaly-axis, a proximal end, and a distal end opposite the proximal end inthe longitudinal y-axis, the implant drill bit comprising: a first drillbit part adjacent the distal end and comprising one or more cuttingedges located at a first peripheral distance from the longitudinaly-axis; and a second drill bit part further from the distal end than thefirst drill bit part and comprising one or more shape cutting edgeshaving a maximum peripheral extent from the longitudinal y-axis locatedat a second peripheral distance from the longitudinal y-axis, whereineach of the one or more shape cutting edges comprises one or more sharppre-cutting edges formed along a protruding flange extending from thesecond peripheral distance of said one or more shape cutting edgestowards the distal end along the longitudinal y-axis, wherein the one ormore sharp pre-cutting edges have a length of 0.3-3 mm, wherein theprotruding flange creates a U-shaped space at the one or more shapecutting edges; and wherein the second peripheral distance is greaterthan the first peripheral distance such that the one or more shapecutting edges and the one or more sharp pre-cutting edges are arrangedto drill a recess for an implant body of a specific implant to beimplanted, which is a larger diameter recess than a recess for animplant post of the specific implant to be implanted the one or morecutting edges of the first drill bit part are arranged to drill.
 5. Thedrill tool according to claim 1, wherein an angle between the one ormore shape cutting edges and the longitudinal y-axis of the drill toolis designed to be 90° or less.
 6. The drill tool according to claim 1,wherein the one or more shape cutting edges are placed peripherallyaround the first drill bit part.
 7. The drill tool according to claim 1,wherein the one or more shape cutting edges comprise a flat surface or asurface which further comprises flanges.
 8. The drill tool according toclaim 1, wherein: the larger diameter implant body recess that the oneor more shape cutting edges and the one or more sharp pre-cutting edgesare arranged to drill corresponds to, or is slightly smaller than, adiameter of the implant body to provide firm attachment in the bone; theimplant post recess that the one or more cutting edges of the firstdrill bit part are arranged to drill corresponds to, or is slightlysmaller than, a diameter of the implant post to provide firm attachmentin the bone; and the curvature of the one or more shape cutting edgescorresponds to the curvature of bone contacting contact surface of thespecific implant to be implanted.
 9. The drill tool according to claim8, wherein the size and shape of the specific implant to be implantedcorresponds in large or partly or substantially to the size and shape ofa cartilage damage in a specific patient.
 10. The drill tool accordingto claim 8, wherein the one or more shape cutting edges in side view aredesigned to correspond to the shape of at least one side of a bonecontacting surface in a cross-sectional view of the specific implant tobe implanted, and wherein the bone contacting surface is substantiallyflat or a bone contacting surface which comprises a protruding anchoringring portion.
 11. The drill tool according to claim 10, wherein the oneor more shape cutting edges are provided with at least one protrudingflange corresponding to said protruding anchoring ring portion.
 12. Thedrill tool according to claim 8, wherein a volume of a part of the drilltool which corresponds to fit the implant is 0.1-5% smaller than avolume of the specific implant to be implanted, allowing for press fitof the implant placed in the larger diameter recess and the smallerdiameter recess made by the drill tool.
 13. The drill tool according toclaim 11, wherein the at least one protruding flange has a lengthcorresponding to the length in a cross-sectional view of said protrudinganchoring ring portion.
 14. The drill tool according to claim 8, whereinan angle between the one or more shape cutting edges and thelongitudinal y-axis is based on a corresponding angle of the specificimplant to be implanted.
 15. The drill tool according to claim 8,wherein length of the first drill bit part is designed to be 2-300 mmcorresponding to, or slightly longer, or 1-5% longer than length of theimplant post of the specific implant to be implanted.
 16. A kitcomprising the drill tool according to claim 8 and the specific implantto be implanted.
 17. The drill tool according to claim 4, wherein theprotruding flange has a width of 0.3-2.0 mm.